First-in-class_medication

First-in-class medication

First-in-class medication

Term for a groundbreaking pharmaceutical drug

A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition.[1] 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.

Examples

More information Drug, Class ...

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.[18] 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.[19]

Costs

A lower number of available therapeutic options correlates with higher prices.[20] In addition, many first-in-class medications are specialty drugs and orphan drugs,[21] which means that manufacturers have to recoup development costs from a smaller market.[22] This raises ethical questions about the sustainability of the high prices on these costs.[23][24]

References

  1. [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]
  2. [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.
  3. [3]
    "Rydapt: Uses, Dosage, Side Effects, Warnings". Drugs.com. Retrieved 2021-07-01.
  4. [4]
    "Rydapt | European Medicines Agency". www.ema.europa.eu. Retrieved 2024-01-16.
  5. [5]
    Office of the Commissioner (2020-03-24). "FDA approves first treatment for thyroid eye disease". FDA. Retrieved 2021-07-01.
  6. [6]
    Center for Drug Evaluation and Research (2020-01-24). "New Drug Therapy Approvals 2019". FDA.
  7. [7]
    "Ocrevus (ocrelizumab) Injection". www.accessdata.fda.gov. Retrieved 2021-07-01.
  8. [8]
    "Search Orphan Drug Designations and Approvals". www.accessdata.fda.gov. Retrieved 2021-07-01.
  9. [9]
    "DailyMed - NEXLETOL- bempedoic acid tablet, film coated". dailymed.nlm.nih.gov. Retrieved 2021-07-01.
  10. [10]
    "Tafamidis Monograph for Professionals". Drugs.com. Retrieved 2021-07-01.
  11. [11]
    "DailyMed - OXBRYTA- voxelotor tablet, film coated". dailymed.nlm.nih.gov. Retrieved 2021-07-01.
  12. [12]
    "DailyMed - ZOKINVY- lonafarnib capsule". dailymed.nlm.nih.gov. Retrieved 2021-07-01.
  13. [13]
    "DailyMed - DUPIXENT- dupilumab injection, solution". dailymed.nlm.nih.gov. Retrieved 2021-07-01.
  14. [14]
    "DailyMed - Search Results for Lasmiditan". dailymed.nlm.nih.gov. Retrieved 2021-07-01.
  15. [15]
    "Tazemetostat Monograph for Professionals". Drugs.com. Retrieved 2021-07-01.
  16. [16]
    "FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes". fda.gov. 13 May 2022. Retrieved 2022-06-30.
  17. [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.
  18. [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.
  19. [19]
    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.
  20. [20]
    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.
  21. [21]
    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.
  22. [22]
    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.
  23. [23]
    Herper, Matthew (2019-12-23). "The debate over America's drug-pricing system is built on myths". STAT. Retrieved 2021-07-01.
  24. [24]
    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.
Share this article:

This article uses material from the Wikipedia article First-in-class_medication, and is written by contributors. Text is available under a CC BY-SA 4.0 International License; additional terms may apply. Images, videos and audio are available under their respective licenses.