First-in-class medication
A first-in-class medication is a
Examples
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.
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
- PMID 23918488.[permanent dead link]
- ^ "BESPONSA 1 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (emc)". www.medicines.org.uk. Retrieved 2021-07-01.
- ^ "Rydapt: Uses, Dosage, Side Effects, Warnings". Drugs.com. Retrieved 2021-07-01.
- ^ "Rydapt | European Medicines Agency". www.ema.europa.eu. Retrieved 2024-01-16.
- ^ Office of the Commissioner (2020-03-24). "FDA approves first treatment for thyroid eye disease". FDA. Retrieved 2021-07-01.
- ^ Center for Drug Evaluation and Research (2020-01-24). "New Drug Therapy Approvals 2019". FDA.
- ^ "Ocrevus (ocrelizumab) Injection". www.accessdata.fda.gov. Retrieved 2021-07-01.
- ^ "Search Orphan Drug Designations and Approvals". www.accessdata.fda.gov. Retrieved 2021-07-01.
- ^ "DailyMed - NEXLETOL- bempedoic acid tablet, film coated". dailymed.nlm.nih.gov. Retrieved 2021-07-01.
- ^ "Tafamidis Monograph for Professionals". Drugs.com. Retrieved 2021-07-01.
- ^ "DailyMed - OXBRYTA- voxelotor tablet, film coated". dailymed.nlm.nih.gov. Retrieved 2021-07-01.
- ^ "DailyMed - ZOKINVY- lonafarnib capsule". dailymed.nlm.nih.gov. Retrieved 2021-07-01.
- ^ "DailyMed - DUPIXENT- dupilumab injection, solution". dailymed.nlm.nih.gov. Retrieved 2021-07-01.
- ^ "DailyMed - Search Results for Lasmiditan". dailymed.nlm.nih.gov. Retrieved 2021-07-01.
- ^ "Tazemetostat Monograph for Professionals". Drugs.com. Retrieved 2021-07-01.
- ^ "FDA Approves Novel, Dual-Targeted Treatment for Type 2 Diabetes". fda.gov. 13 May 2022. Retrieved 2022-06-30.
- PMID 28032825.
- ^ S2CID 32258945.
- ^ 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.
- S2CID 211111984.
- PMID 28784733.
- .
- ^ Herper, Matthew (2019-12-23). "The debate over America's drug-pricing system is built on myths". STAT. Retrieved 2021-07-01.
- ISSN 0196-0644.