Els motius i les conseqüències de l'elevat preu dels medicaments

Prescription for the People

El contingut del llibre (orientat als USA):

Introduction

Part I

1. People Everywhere Are Struggling to Get the Medicines They Need

2. The United States Has a Drug Problem

3. Millions of People Are Dying Needlessly

4. Cancer Patients Face Particularly Deadly Barriers to Medicines

5. The Current Medicine System Neglects Many Major Diseases

Part II

6. Corporate Research and Development Investments Are Exaggerated

7. The Current System Wastes Billions on Drug Marketing

8. The Current System Compromises Physician Integrity and Leads to Unethical Corporate Behavior

9. Medicines Are Priced at Whatever the Market Will Bear

10. Pharmaceutical Corporations Reap History-Making Pro ts

Part III

11. The For-Profit Medicine Arguments Are Patently False

12. Medicine Patents Are Extended Too Far and Too Wide

13. Patent Protectionism Stunts the Development of New Medicines

14. Governments, Not Private Corporations, Drive Medicine Innovation

15. Taxpayers and Patients Pay Twice for Patented Medicines

Part IV

16. Medicines Are a Public Good

17. Medicine Patents Are Arti cial, Recent, and Government-Created

18. The United States and Big Pharma Play the Bully in Extending Patents

19. Pharma-Pushed Trade Agreements Steal the Power of Democratically Elected Governments

Part V

20. Current Law Provides Opportunities for Affordable Generic Medicines

21. There Is a Better Way to Develop Medicines

22. Human Rights Law Demands Access to Essential Medicines

Conclusion

Notes

Index

Repensar la innovació en medicaments

 Rethinking Innovation in Drugs: A Pathway to Health for All

En un article recent la Mariana Mazucatto insisteix en el seu argument. És prou conegut i alhora encara convé insistir més. Cal reconèixer el paper del finançament públic a la recerca i innovació en nous medicaments. L'exemple de Moderna i la vacuna de la Covid és prou clar i ja l'he explicat anteriorment. Moderna va rebre 1000 milions $ del govern en ajudes per la recerca i alhora va comprar 1500 milions $ en vacunes per a 100 milions de dosis. El total dedicat pel govern nordamericà a la tecnologia de vacunes mRNA va ser de 31.900 milions $.

Els missatges:

• It is essential to recognize that health innovation emerges from collective intelligence
• It is imperative to bolster financial commitments to medical research and development, viewing this as a strategic long-term investment rather than a short-term expenditure, and to protect existing budgets
• It is crucial to leverage procurement mechanisms to shape market opportunities that align with public health needs  

Malgrat que el finançament és imprescindible, cal una nova governança de la innovació. Unes noves prioritats de recerca i una revisió del problema de les patents. Una proposta que ja s'ha fet moltes vegades però que ningú gosa encapçalar. En altres ocasions ja ho he explicat. Malgrat que les regles del mercat són transnacionals, els governs actuen a l'àmbit nacional. S'han creat organismes multilaterals per garantir el comerç mundial però no per a la regulació necessària de la política sanitària. La OMS en aquest sentit i a l'àmbit dels medicaments afegeix poc.

La Mariana Mazucatto resumeix en aquest article la seva posició sobre la innovació al sector farmacèutic. Ho ha dit en altres llocs, però insisteix que cal una nova governança de la innovació. Bàsicament el missatge és que el govern no pot restar passiu com ara. Reprodueixo el paràgraf clau:

While funding is essential, it alone is not the solution. Government should adopt a mission-oriented approach to drug innovation, setting bold goals related to public health that serve to catalyze innovation and investment — goals that prioritize improved patient outcomes, reduction in disease prevalence, and access equity.Achieving such bold goals would necessitate a reform of intellectual property rights. Moreover, it would require a shift in how collaborations between the public and private sectors are structured to recognize that innovation results from a collective effort, valuing contributions from both public and private entities. And it would require governments to foster collaboration across different ministries, thereby avoiding the compartmentalized governance of health. The excessive tendency of governments to outsource key operations has unfortunately weakened these capacities.

Monet, ara a Orsay

 

La teranyina que sosté la financialització dels medicaments, la salut i la vida (2)

 Sick with “Shareholder Value”: US Pharma’s Financialized Business Model During the Pandemic

Als USA, la Inflation Reduction Act ha obert la caixa dels trons. La possibilitat que el govern pugui negociar els preus dels medicaments finançats públicament ha desesperat a la indústria que ha engegat una campanya de lobby inusual. Es tracta de protegir els preus alts perquè altrament no hi haurà innovació, això diuen. Però malgrat aquesta campanya, fa pocs dies el WP ja deia que no se n'han sortit i que estem propers a grans canvis, que es resumeixen en aquests 6:

1) Drug price negotiation

2) A cap on out-of-pocket spending

3) Lower prices for insulin

4) Free vaccines

5) Inflation penalty for drug manufacturers. 

6) Extra help for the most vulnerable

El govern vol estalviar fins a 100.000 milions $ en aquests propers anys. I destacaria especialment, això de que si volen augmentar el preu més que la inflació (d'aquells medicaments ja en el mercat) hauran de fer descomptes al finançador públic. Dissuasió per tant de provocar preus excessius.

I aquí és on entra Wall Street que ho rebutja de dalt a baix i que ho veu com una amenaça al model de financialització que ha funcionat fins ara. Diuen que fins a 100 medicaments ja no arribaran al mercat. I aquesta amenaça no creïble no és certa perquè sabem això:

Data for the 474 corporations included in the S&P 500 Index in January 2022 and publicly traded from 2012 through 2021 reveal that these corporations distributed $5.7 trillion as share repurchases during the 2012-2021 fiscal years, representing 55 percent of net income, and $4.2 trillion as dividends, an additional 41 percent of net income.

Les recompres d'accions a la borsa per part de les companyies són un 13% superiors al que dediquen a la innovació.

As shown in Table 1, for the decade 2012-2021, distributions to shareholders by the 14 pharmaceutical companies that were among the 474 S&P 500 companies in the database represented 110 percent of net income,7 a larger proportion than the highly financialized 96 percent for all 474 companies. At 55 percent, the stock buybacks of the subset of pharmaceutical companies was the same proportion of net income as the 474 companies, but, at 54 percent versus 41 percent, pharmaceutical dividends as a proportion of net income far exceeded that of all the companies in the dataset. The 14 pharmaceutical companies accounted for 3.1 percent of the revenues of all 474 companies but 6.6 percent of the net income, 6.6 percent of the buybacks, and 8.8 percent of the dividends. The $747 billion that the pharmaceutical companies distributed to shareholders was 13 percent greater than the $660 billion that these corporations expended on research & development over the decade.

En aquest article de Lazonick hi trobareu molts més detalls sobre com ha canviat el model de negoci amb la biotecnologia. Si amb el model anterior el paper de la borsa era el típic de separació de propietat-control, en el nou les opas eren la forma de control per part de fons de capital-risc i després el paper del NASDAQ va oferir opcions d'entrada i sortida que abans no existien. L'article ho explica magníficament, no ho he vist enlloc més. La interacció de les recompres d'accions amb retribució escandalosa als directius de les companyies farmacèutiques esdevé una cosa mai vista a cap altra indústria.

Any 2021, el màxim directiu de Regeneron va ingressar 452 milions de $. No cal dir res més, tota la taula és una desmesura.

Què cal fer segons Lazonick?. El canvi en la regulació de preus és només el primer pas. Cal prohibir la recompra d'accions, deslligar el pagament dels directius dels valors de l'acció a borsa, posar representants dels accionistes al consell, reformar la fiscalitat de les empreses, encoratjar carreres professionals. 

Molta feina per endavant si es vol capgirar la tendència de financialització dels medicaments que vivim. Altrament, un avís, tot el que als USA es disminueixi com ingressos, voldran que sigui compensat amb fons provinents d'altres països. Per tant cal estar alerta als moviments propers i avançar-se als esdeveniments.

 

Els medicaments que venen i els que ja s'han aprovat el 2023

És bo fer una ullada a quins són els medicaments que previsiblement s'aprovaran l'any 2024, i els de Nature diuen que són aquests:

Medicaments per aprovar el 2024

Biologic name	Sponsor	Properties	Indication	Timing
Zolbetuximab	Astellas	Claudin 18.2-targeted mAb	Gastric cancer	January
Lifileucel	Iovance	Tumour-infiltrating lymphocyte therapy	Melanoma	February
Resmetiroma	Madrigal/Synta	Thyroid hormone receptor β agonist	NASH	March
Sotatercepta	Merck & Co./Acceleron	Fusion protein ligand trap for TGF-β superfamily	PAH	March
mRNA-1345a	Moderna	mRNA-based vaccine	RSV prevention	April
Donanemaba	Eli Lilly	Amyloid-β-targeted mAb	Alzheimer disease	Q1
EB-101a	Abeona	Gene therapy with COL7A2 transgene	RDEB	May
Patritumab deruxtecana	Merck & Co.	HER3-targeted ADC	NSCLC	June
Imetelstat	Geron	Telomerase inhibitor	Transfusion-dependent anaemia with MDS	June
Tarlatamaba	Amgen	DLL3 × CD3 T-cell engager antibody	SCLC	June
Fidanacogene elaparvoveca	Pfizer/Spark	AAV-based gene therapy with factor IX transgene	Hemophilia B	Q2
Bentracimaba	Laboratoires SERB	Ticagrelor-neutralizing antibody	Drug toxicity	1H
Crovalimaba	Roche	C5-targeted mAb	PNH	July
Danicopana	AstraZeneca/Alexion	Factor D inhibitor	PNH	July
Midomafetaminea	MAPS	MDMA	PTSD	August
Xanomeline plus trospium	Karuna/BMS	Muscarinic receptor modulators	Schizophrenia	September
Acoramidis	BridgeBio	TTR stabilizer	TTR amyloidosis	December
Marstacimab	Pfizer	TFPI-targeted mAb	Haemophilia A and B	Q4
Afamitresgene autoleucela	Adaptimmune	MAGE-A4-targeted autologous, engineered T cell therapy	Synovial sarcoma	2024

aBreakthrough designated drug. AAV, adeno-associated virus; ADC, antibody–drug conjugate; mAb, monoclonal antibody; MDS, myelodysplastic syndromes; NASH, non-alcoholic steatohepatitis; NSCLC, non-small-cell lung cancer; PAH, pulmonary arterial hypertension; PNH, paroxysmal nocturnal haemoglobinuria; PTSD, post-traumatic stress disorder; RDEB, recessive dystrophic epidermolysis bullosa; RSV, respiratory syncytial virus; SCLC, small-cell lung cancer; TFPI, tissue factor pathway inhibitor; TTR, transthyretin. Source: BioMedTracker and press releases.

També és bo de veure què ha passat amb l'aprovació de medicaments per la FDA el 2023 i resulta que s'ha arribat a 55 nous medicaments, una xifra considerable si observem el que passava els anys anteriors, només superada el 2018

Fig. 1 | 30 years of novel FDA approvals. Annual numbers of new molecular entities (NMEs) and biologics license applications (BLAs) approved by the FDA’s Center for Drug Evaluation and Research (CDER). See Table 1 for new approvals in 2023. Products approved by the Center for Biologics Evaluation and Research (CBER), including vaccines and gene therapies, are not included in this drug count (Table 2). Source: FDA.

Fig. 2 | CDER approvals by therapeutic area. Indications that span multiple therapeutic areas are classified under only one, based on which FDA office and division reviewed the approval application. Sources: Nature Reviews Drug Discovery, FDA.

Fig. 3 | CDER approvals by modality. Small molecules, including peptides of up to 40 amino acids in length, and oligonucleotides are approved as new molecular entities (NMEs). Protein-based candidates are approved through biologics license applications (BLAs). mAb, monoclonal antibody; siRNA, small interfering RNA. Source: Nature Reviews Drug Discovery.

I la notícia de l'any ha estat CRISPR:

Vertex and CRISPR Therapeutics’ exagamglogene autotemcel (exa-cel; Casgevy) especially is the first CRISPR–Cas9-based gene editor to secure a green light from the FDA, winning an approval for sickle cell disease (SCD). Exa-cel is an ex vivo gene-edited cell therapy: blood cells are harvested from patients, genetically modified at the BCL11a transcription factor to re-enable fetal haemoglobin production, and then re-infused into patients. The therapeutically upregulated fetal haemoglobin compensates for the defects in β-haemoglobin that cause the diseases. Clinical data shows that the gene therapy has curative potential, although longer-term data are needed to assess the durability of the effect.

When Harvard Medical School and HHMI’s Stuart Orkin and colleagues discovered the role of BCL11a in fetal haemoglobin production in 2008, it was unclear how to drug the transcription factor. The arrival of CRISPR–Cas9 gene-editing system in 2012 provided a path forward for haemoglobinopathies. The development of the programme was “remarkably fast”, said Orkin. “It is a perfect example of how the ecosystem can work.”

Vertex and CRISPR have priced the one-off treatment at $2.2 million. It also requires a harsh preconditioning chemotherapy regimen, to make room for the edited cells. The therapy will consequently remain out of reach for many patients. “This is not the end game,” says Orkin, who has his eye on next-generation gene editors and small molecules that might be more accessible.

PS. Un breu missatge per aquells que mitjançant la seva recerca "obren la porta" a tractaments i ho expliquen al Telenotícies. No n'hi ha cap d'aquesta llista del 2024 ni del 2023 d'aquí sota que sigui un d'ells, la porta segueix oberta, o potser no hi havia porta per obrir. Millor no haver d'estar sentint això sempre, sense explicar-ne el resultat.

PS. La història de exa-cel.

PS. The economist sobre el tema

PS. El llistat de medicaments:

Table 1 | CDER approvals in 2023

Drug (brand name)	Sponsor	Properties	Indication
Lecanemab (Leqembi)a	Eisai/Biogen	Amyloid-β-targeted mAb	Alzheimer disease
Bexagliflozin (Brenzavvy)	Theracosbio	SGLT2 inhibitor	Glycaemic control in type 2 diabetes mellitus
Pirtobrutinib (Jaypirca)	Loxo/Eli Lilly	BTK inhibitor	Mantle cell lymphoma
Elacestrant (Orserdu)	Stemline	ER antagonist	ER-positive, HER2-negative, ESR1-mutant breast cancer
Daprodustat (Jesduvroq)	GSK	HIF-PH inhibitor	Anaemia caused by CKD for adults on dialysis
Velmanase alfa (Lamzede)a	Chiesi	Recombinant α-mannosidase	Non-CNS manifestations of α-mannosidosis
Sparsentan (Filspari)	Travere	Endothelin and angiotensin II receptor antagonist	Proteinuria in primary IgA nephropathy
Omaveloxolone (Skyclarys)	Reata/Biogen	Mechanism unknown, NRF2 activator	Friedrich’s ataxia
Zavegepant (Zavzpret)	Pfizer	CGRP receptor antagonist	Migraine
Trofinetide (Daybue)	Acadia	Mechanism unknown	Rett syndrome
Retifanlimab (Zynyz)a	Incyte	PD1-targeted mAb	Merkel cell carcinoma
Rezafungin (Rezzayo)	Cidara	Echinocandin antifungal	Candidemia and invasive candidiasis
Leniolisib (Joenja)	Pharming	PI3Kδ inhibitor	Activated PI3Kδ syndrome
Tofersen (Qalsody)	Biogen	SOD1-targeted ASO	SOD1 amyotrophic lateral sclerosis
Pegunigalsidase alfa (Elfabrio)a	Chiesi	PEGylated recombinant α-galactosidase Α	Fabry disease
Fezolinetant (Veozah)	Astellas	Neurokinin 3 receptor antagonist	Hot flashes caused by menopause
Perfluorohexyloctane (Miebo)	Bausch + Lomb	Semifluorinated alkane	Dry eye disease
Epcoritamab (Epkinly)a	Genmab/AbbVie	CD20 × CD3 T-cell engager	DLBCL and high-grade B-cell lymphoma
Sulbactam, durlobactam (Xacduro)	Entasis	β-lactam antibacterial plus a β-lactamase inhibitor	Hospital-acquired and ventilator-associated bacterial pneumonia caused by susceptible ABC
Nirmatrelvir, ritonavir (Paxlovid)	Pfizer	SARS-CoV-2 main protease inhibitor plus a CYP3A inhibitor	Mild-to-moderate COVID-19
Flotufolastat F18 (Posluma)	Blue Earth	Radioactive diagnostic agent	PET imaging in prostate cancer
Sotagliflozin (Inpefa)	Lexicon	SGLT1/2 inhibitor	Heart failure
Glofitamab (Columvi)a	Genentech	CD20 × CD3 T-cell engager	DLBLC or large B-cell lymphoma
Ritlecitinib (Litfulo)	Pfizer	JAK3 inhibitor	Alopecia areata
Rozanolixizumab (Rystiggo)a	UCB	FcRn-targeted mAb	AChR- or MuSK-antibody-positive gMG
Somatrogon (Ngenla)a	Pfizer	Human growth hormone analogue	Growth hormone deficiency
Nirsevimab (Beyfortus)a	AstraZeneca	RSV F protein-targeted mAb	RSV lower respiratory tract disease
Quizartinib (Vanflyta)	Daiichi Sankyo	FLT3 kinase inhibitor	AML
Lotilaner (Xdemvy)	Tarsus	Ectoparasiticide	Demodex blepharitis
Zuranolone (Zurzuvae)	Sage	GABAA receptor PAM	Postpartum depression
Avacincaptad pegol (Izervay)	Iveric/Astellas	C5-targeted aptamer	Geographic atrophy secondary to AMD
Talquetamab (Talvey)a	Janssen	GPRC5D × CD3 T-cell engager	Multiple myeloma
Elranatamab (Elrexfio)a	Pfizer	BCMA × CD3 T-cell engager	Multiple myeloma
Palovarotene (Sohonos)	Ipsen	Retinoic acid receptor agonist	Fibrodysplasia ossificans progressiva
Pozelimab (Veopoz)a	Regeneron	C5-targeted mAb	CHAPLE disease
Motixafortide (Aphexda)	Biolinerx	CXCR4 inhibitor	Hematopoietic stem cell mobilization for autologous transplantation in multiple myeloma
Momelotinib (Ojjaara)	GSK	JAK1/2, ALK2 inhibitor	Myelofibrosis in adults with anaemia
Gepirone (Exxua)	Fabre-Kramer	5HT1A receptor agonist	Major depressive disorder
Cipaglucosidase alfa (Pombiliti)a	Amicus	Recombinant α-glucosidase	Pompe disease
Nedosiran (Rivfloza)	Novo Nordisk	LDHA-targeted siRNA	Primary hyperoxaluria type 1
Etrasimod (Velsipity)	Pfizer	S1P receptor modulator	Ulcerative colitis
Zilucoplan (Zilbrysq)	UCB	Complement C5 inhibitor	AChR-antibody positive gMG
Bimekizumab (Bimzelx)a	UCB	IL-17A/F-targeted mAb	Plaque psoriasis
Vamorolone (Agamree)	Santhera	Corticosteroid	Duchenne muscular dystrophy
Mirikizumab (Omvoh)a	Eli Lilly	IL-23-targeted mAb	Ulcerative colitis
Toripalimab (Loqtorzi)a	Coherus	PD1-targeted mAb	Nasopharyngeal carcinoma
Fruquintinib (Fruzaqla)	Takeda	VEGFR1/2/3 kinase inhibitor	Colorectal cancer
Taurolidine, heparin (Defencath)	Cormedix	Thiadiazinane antimicrobial plus an anticoagulant	Incidence of catheter-related bloodstream infections
Repotrectinib (Augtyro)	Bristol Myers Squibb	ROS1 and TRK kinase inhibitor	ROS1-positive NSCLC
Efbemalenograstim alfa (Ryzneuta)a	Evive	Recombinant leukocyte growth factor	Neutropenia
Capivasertib (Truqap)	AstraZeneca	AKT kinase inhibitor	Breast cancer
Nirogacestat (Ogsiveo)	Springworks	γ-secretase inhibitor	Desmoid tumours
Iptacopan (Fabhalta)	Novartis	Complement factor B inhibitor	Paroxysmal nocturnal haemoglobinuria
Birch triterpenes (Filsuvez)	Chiesi	Mechanism unknown	Epidermolysis bullosa
Eplontersen (Wainua)	Ionis/AstraZeneca	TTR-targeted ASO	hATTR with polyneuropathy

aBiologic approval. A, accelerated; ABC, Acinetobacter baumannii-calcoaceticus complex; AChR, anti-acetylcholine receptor; AMD, age-related macular degeneration; AML, acute myelogenous leukaemia; ASO, antisense oligonucleotide; B, breakthrough; CGRP, calcitonin gene-related peptide; CKD, chronic kidney disease; CNS, central nervous system; DLBCL, diffuse large B-cell lymphoma; ESR1, estrogen receptor 1; ER, estrogen receptor; FcRn, neonatal Fc receptor; gMG, generalized myasthenia gravis; hATTR, hereditary TTR amyloidosis; HER2, human epidermal growth factor receptor 2; HIF-PH, hypoxia-inducible factor prolyl hydroxylase; IgA, immunoglobulin A; mAb, monoclonal antibody; MuSK, muscle-specific tyrosine kinase; NSCLC, non-small-cell lung cancer; O, orphan; P, priority; PAM, positive allosteric modulator; PD1, programmed death receptor 1; RSV; respiratory syncytial virus; S, standard; S1P, sphingosine 1-phosphate; siRNA, small interfering RNA; TTR, transthyretin. Source: Drugs@FDA.

Table 2 | Selected CBER approvals in 2023

Biologic name (brand)	Sponsor	Properties	Indication
Fc-vwf-xten fusion protein (Altuviiio)	Bioverativ	Recombinant antihaemophilic factor	Haemophilia A
Omidubicel (Omisirge)	Gamida Cell	Nicotinamide modified allogeneic haematopoietic progenitor cell therapy	Neutrophil recovery in patients with haematologic malignancies
Fecal microbiota spores, live (Vowst)	Seres	Bacterial spore suspension in capsules for oral administration	C. difficile recurrence
RSV vaccine, adjuvanted (Arexvy)	GSK	Stabilized prefusion F subunit vaccine	RSV prevention, in over 60s
Beremagene geperpavec (Vyjuvek)	Krystal	HSV-based gene therapy with COL7A1 transgene	Skin wounds in COL7A1-mutated DEB
RSV vaccine (Abrysvo)	Pfizer	Bivalent stabilized prefusion F subunit vaccine	RSV prevention, in over 60s and pregnant women
Delandistrogene moxeparvovec (Elevidys)	Sarepta	AAV-based gene therapy with a micro-dystrophin transgene	DMD patients aged 4–5
Donislecel (Lantidra)	Celltrans	Allogeneic pancreatic islets	Type 1 diabetes patients unable to approach target HbA1c
Valoctocogene roxaparvovec (Roctavian)	Biomarin	AAV-based gene therapy with modified factor VIII transgene	Haemophilia A
Anthrax vaccine adsorbed, adjuvanted (Cyfendus)	Emergent	Protective antigen protein-based vaccine	Post-exposure prophylaxis
Prothrombin complex concentrate, human (Balfaxar)	Octapharma	Prothrombin complex concentrate containing factor II, VII, IX and X, and proteins C and S	Urgent warfarin reversal
Meningococcal groups A, B, C, W, and Y vaccine (Penbraya)	Pfizer	Conjugate and recombinant protein vaccine, pentivalent	Meningococcal disease prevention
Chikungunya vaccine, live (Ixchiq)	Valneva	Live, attenuated chikungunya virus vaccine	Chikungunya virus prevention
ADAMTS13, recombinant (Adzynma)	Takeda	Recombinant rADAMTS13	cTTP
Exagamglogene autotemcel (Casgevy)	Vertex/CRISPR	CRISPR–Cas9-based BCL11a-gene-editing therapy	Sickle cell disease
Lovotibeglogene autotemcel (Lyfgenia)	Bluebird	Lentivirus-based gene therapy with HbAT87Q transgene	Sickle cell disease

AAV, adeno-associated virus; C. difficile, Clostridioides difficile; cTTP, congenital thrombotic thrombocytopenic purpura; DEB, dystrophic epidermolysis bullosa; DMD, Duchenne muscular dystrophy; HbA1c; glycated haemoglobin; HSV, herpes simplex virus; RSV, respiratory syncytial virus. Source: FDA.

 PS. I els medicaments que no s'han aprovat:

Table 3 | Selected rejected drugs of 2023

Drug	Sponsor	Properties	Indication
Donanemab	Eli Lilly	Amyloid-β-targeted mAb	Alzheimer disease
Omecamtiv mecarbil	Cytokinetics	Myosin activator	Chronic heart failure
Inbakicept	ImmunityBio	IL-15 agonist fusion protein	Bladder cancer
Concizumab	Novo Nordisk	TFPI-targeted mAb	Haemophilia A and B
Obeticholic acid (Ocaliva)a	Alfasigma	Farnesoid X receptor agonist	NASH
Zuranolone (Zurzuvae)b	Sage	GABAA receptor PAM	MDD
Avasopasem manganese	Galera	Superoxide dismutase mimetic	Mucositis
Lebrikizumab	Eli Lilly	IL-13-targeted mAb	Atopic dermatitis
Gefapixant	Merck & Co.	P2X3 receptor antagonist	Chronic cough