US regulators are reportedly gearing up to revoke breakthrough status for Bristol-Myers Squibb’s hepatitis C drug daclatasvir, just days after it emerged that Merck & Co’s hep C combo will suffer the same fate.
The US Food and Drug Administration has informed the drugmaker that it intends to take back breakthrough designation for regimens containing dachatasvir “due to the evolving HCV treatment landscape”, according to FierceBiotech.
Though undoubtedly disappointing for the firm, the decision should not affect timings for its New Drug Application for the drug, it stressed.
Last week Merck & Co said alongside its financials that it had been notified by the FDA of its intent to rescind Breakthrough Therapy Designation status for its grazoprevir/elbasvir (MK-5172/MK-8742) HCV combination treatment regimen, citing the availability of other recently approved treatments for Genotype 1 patients.
Merck also noted that it will be discussing the matter with the regulator ”and does not expect that it will impact its ability to file an NDA for this combination regimen or the timing of that filing”.