- Just how much have Gilead and AbbVie changed the hepatitis C landscape? FierceBiotech reports that Bristol-Myers Squibb is joining Merck at the back of the HCV line as the FDA plans to revoke breakthrough designation for BMS' new daclatasvir-based hep C treatment.
- Last week, Merck's breakthrough designation for its hep C treatment (MK-5172/MK-8742) was also rescinded by the FDA.
- Both companies still plan to move forward with the review process for these hep C candidates.
One of the FDA's criteria for a drug to receive breakthrough designation is that there must be "preliminary clinical evidence, which indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development."
Once upon a time, BMS's daclatasvir and its extended hepatitis C development program was ahead of the competition in developing breakthrough, game-changing treatments for type 1 genotypes of hepatitis C, but that changed when daclatasvir signaled serious risks during clinical trials. Since then, BMS has retrenched and reconfigured its approach to gaining approvals and combining various compounds to advance its hep C program.
Nonetheless, the fact is that Gilead and AbbVie are already ahead of the game, focusing on working with payers to negotiate discounts and gain market share for their hep C treatments—both of which retained their breakthrough therapy designations and benefited from an expedited review process.