Term for a groundbreaking pharmaceutical drug
Afirst-in-class medication is aprototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition.[ 1] 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 asbreakthrough therapies ,Regenerative Medicine Advanced Therapies and/ororphan drugs , first-in-class status itself has no regulatory effect.
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 investigatingrecalls and warnings in relation to first-in-class drugs approved between 1997 and 2012 byHealth Canada has found that first-in-class drugs actually have a more favourable benefit-to-harm ratio.[ 17]
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] blockbuster drugs (drugs with annual sales revenues exceedingUS$1,000,000,000 ) were not first-in-class drugs.[ 18] health insurers to restrict whatspecialty drugs are covered and prevent incumbency advantages.[ 19]
A lower number of available therapeutic options correlates with higher prices.[ 20] specialty drugs andorphan drugs ,[ 21] [ 22] [ 23] [ 24]
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