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First-in-class medication
Term for groundbreaking pharmaceutical

A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medications and reports on them annually, first-in-class is not considered a regulatory category. Although many first-in-class medications qualify as breakthrough therapies, Regenerative Medicine Advanced Therapies and/or orphan drugs, first-in-class status itself has no regulatory effect.

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Examples

DrugClassTargeted conditionsYear approved

(FDA)

Year approved

(EMA)

Inotuzumab ozogamicin

(Besponsa)

Anti-CD22 monoclonal antibody-drug conjugateRelapsed or refractory B cell precursor acute lymphoblastic leukemia22017
Tagraxofusp

(Elzonris)

Interleukin 3-diphtheria toxin fusion protein targeting plasmacytoid dendritic cellsBlastic plasmacytoid dendritic cell neoplasm20182021
Midostaurin

(Rydapt)

Multi-target tyrosine kinase inhibitor not inhibited by the D816V cKit mutationSystemic mastocytosis, myelodysplastic syndrome, acute myeloid leukemia3201720174
Teprotumumab

(Tepezza)

Anti-IGF-1R monoclonal antibodyGraves' ophthalmopathy52020
Romosozumab

(Evenity)

Anti-sclerostin monoclonal antibodyOsteoporosis620192019
Ocrelizumab

(Ocrevus)

Anti-CD20 monoclonal antibodyMultiple sclerosis720172018
Ivosidenib

(Tibsovo)

Small molecule inhibitor of isocitrate dehydrogenase 1Acute myeloid leukemia, cholangiocarcinoma820182023
Bempedoic acid

(Nexletol)

Adenosine triphosphate-citrate lyase inhibitorHypercholesterolemia920202020
Tafamidis

(Vyndaqel, Vyndamax)

Transthyretin chaperone (stabilizer)Familial amyloid polyneuropathy and other transthyretin amyloidoses1020112019
Voxelotor

(Oxbryta)

Hemoglobin oxygen affinity modulatorSickle cell disease112019
Lonafarnib

(Zokinvy)

Farnesyltransferase inhibitorHutchinson-Gilford progeria syndrome1220202022
Dupilumab

(Dupixent)

Interleukin-4 receptor alpha subunit inhibitorAsthma, atopic dermatitis, allergic diseases132017
Lasmiditan

(Reyvow)

Selective 5-HT1F serotonin receptor agonistMigraine1420192022
Tazemetostat

(Tazverik)

Selective EZH2 inhibitorEpithelioid sarcoma152020
Tirzepatide

(Mounjaro)

GLP-1 and GIP activatoradult type 2 diabetes1620222022

Controversy

Safety

By definition, a first-in-class drug does not have the safety evidence from analogous products that not-first-in-class drugs would have. However, a study investigating recalls and warnings in relation to first-in-class drugs approved between 1997 and 2012 by Health Canada has found that first-in-class drugs actually have a more favourable benefit-to-harm ratio.17

Economics

First-in-class drugs are often seen as commercially more attractive as they may tap into a market segment that has hitherto been underserved, but this may be illusory.18 In fact, most blockbuster drugs (drugs with annual sales revenues exceeding US$1,000,000,000) were not first-in-class drugs.19 The economic potential of a first-in-class drug, which is typically priced higher than later drugs in the same class, has been largely declining due to efforts by health insurers to restrict what specialty drugs are covered and prevent incumbency advantages.20

Costs

A lower number of available therapeutic options correlates with higher prices.21 In addition, many first-in-class medications are specialty drugs and orphan drugs,22 which means that manufacturers have to recoup development costs from a smaller market.23 This raises ethical questions about the sustainability of the high prices on these costs.2425

References

  1. Lanthier, Michael; Miller, Kathleen L.; Nardinelli, Clark; Woodcock, Janet (2013-08-01). "An Improved Approach To Measuring Drug Innovation Finds Steady Rates Of First-In-Class Pharmaceuticals, 1987–2011". Health Affairs. 32 (8): 1433–1439. doi:10.1377/hlthaff.2012.0541. ISSN 0278-2715. PMID 23918488.[permanent dead link‍] https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2012.0541 ↩

  2. "BESPONSA 1 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (emc)". www.medicines.org.uk. Retrieved 2021-07-01. https://www.medicines.org.uk/emc/medicine/33679 ↩

  3. "Rydapt: Uses, Dosage, Side Effects, Warnings". Drugs.com. Retrieved 2021-07-01. https://www.drugs.com/rydapt.html ↩

  4. "Rydapt | European Medicines Agency". www.ema.europa.eu. Retrieved 2024-01-16. https://www.ema.europa.eu/en/medicines/human/EPAR/rydapt ↩

  5. Office of the Commissioner (2020-03-24). "FDA approves first treatment for thyroid eye disease". FDA. Retrieved 2021-07-01. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-thyroid-eye-disease ↩

  6. Center for Drug Evaluation and Research (2020-01-24). "New Drug Therapy Approvals 2019". FDA. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/new-drug-therapy-approvals-2019 ↩

  7. "Ocrevus (ocrelizumab) Injection". www.accessdata.fda.gov. Retrieved 2021-07-01. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000TOC.cfm ↩

  8. "Search Orphan Drug Designations and Approvals". www.accessdata.fda.gov. Retrieved 2021-07-01. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=481515 ↩

  9. "DailyMed - NEXLETOL- bempedoic acid tablet, film coated". dailymed.nlm.nih.gov. Retrieved 2021-07-01. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=88d06d89-a3da-40b4-b273-8f4f7d56c4c9 ↩

  10. "Tafamidis Monograph for Professionals". Drugs.com. Retrieved 2021-07-01. https://www.drugs.com/monograph/tafamidis.html ↩

  11. "DailyMed - OXBRYTA- voxelotor tablet, film coated". dailymed.nlm.nih.gov. Retrieved 2021-07-01. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c557fac-29ec-483f-b691-8a935d4decc3 ↩

  12. "DailyMed - ZOKINVY- lonafarnib capsule". dailymed.nlm.nih.gov. Retrieved 2021-07-01. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=956a142f-35d6-4fe3-8aef-7e4878d275ed ↩

  13. "DailyMed - DUPIXENT- dupilumab injection, solution". dailymed.nlm.nih.gov. Retrieved 2021-07-01. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=595f437d-2729-40bb-9c62-c8ece1f82780 ↩

  14. "DailyMed - Search Results for Lasmiditan". dailymed.nlm.nih.gov. Retrieved 2021-07-01. https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Lasmiditan ↩

  15. "Tazemetostat Monograph for Professionals". Drugs.com. Retrieved 2021-07-01. https://www.drugs.com/monograph/tazemetostat.html ↩

  16. "FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes". fda.gov. 13 May 2022. Retrieved 2022-06-30. https://www.fda.gov/news-events/press-announcements/fda-approves-novel-dual-targeted-treatment-type-2-diabetes ↩

  17. Lexchin, Joel (November 2016). "How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study". Healthcare Policy. 12 (2): 65–75. ISSN 1715-6572. PMC 5221712. PMID 28032825. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5221712 ↩

  18. Schulze, Ulrik; Ringel, Michael (2013-06-01). "What matters most in commercial success: first-in-class or best-in-class?". Nature Reviews Drug Discovery. 12 (6): 419–420. doi:10.1038/nrd4035. ISSN 1474-1784. PMID 23722339. S2CID 32258945. https://www.nature.com/articles/nrd4035 ↩

  19. Schulze, Ulrik; Ringel, Michael (2013-06-01). "What matters most in commercial success: first-in-class or best-in-class?". Nature Reviews Drug Discovery. 12 (6): 419–420. doi:10.1038/nrd4035. ISSN 1474-1784. PMID 23722339. S2CID 32258945. https://www.nature.com/articles/nrd4035 ↩

  20. Longman, Roger (20 July 2015). "The Shrinking Value of Best-in-Class and First-in-Class Drugs". In Vivo by Informa Pharma Intelligence. Retrieved 1 July 2021. https://invivo.pharmaintelligence.informa.com/IV004399/The-Shrinking-Value-Of-Best-In-Class-And-First-In-Class-Drugs ↩

  21. Kwa, Michael C.; Tegtmeyer, Kyle; Welty, Leah J.; Raney, Sam G.; Luke, Markham C.; Xu, Shuai; Kong, Betty (2020-10-01). "The relationship between the number of available therapeutic options and government payer (medicare part D) spending on topical drug products". Archives of Dermatological Research. 312 (8): 559–565. doi:10.1007/s00403-020-02042-9. ISSN 1432-069X. PMID 32055932. S2CID 211111984. https://doi.org/10.1007/s00403-020-02042-9 ↩

  22. Chambers, James D.; Thorat, Teja; Wilkinson, Colby L.; Neumann, Peter J. (2017-08-01). "Drugs Cleared Through The FDA's Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process". Health Affairs. 36 (8): 1408–1415. doi:10.1377/hlthaff.2016.1541. ISSN 0278-2715. PMID 28784733. https://doi.org/10.1377%2Fhlthaff.2016.1541 ↩

  23. Lieberman, Steven M.; Ginsburg, Paul B.; Patel, Kavita K. (2020). "Balancing Lower U.S. Prescription Drug Prices And Innovation – Part 1 | Health Affairs Blog". Health Affairs Forefront. doi:10.1377/forefront.20201123.804451. https://www.healthaffairs.org/do/10.1377/forefront.20201123.804451/full/ ↩

  24. Herper, Matthew (2019-12-23). "The debate over America's drug-pricing system is built on myths". STAT. Retrieved 2021-07-01. https://www.statnews.com/2019/12/23/debate-over-us-drug-pricing-system-time-to-face-reality/ ↩

  25. Greene, Jan (January 2017). "EpiPen Controversy Reveals Complexity Behind Drug Price Tags". Annals of Emergency Medicine. 69 (1): A16 – A19. doi:10.1016/j.annemergmed.2016.10.025. ISSN 0196-0644. https://www.annemergmed.com/article/S0196-0644(16)31329-4/fulltext ↩