Merck, BMS Could Lose Breakthrough Therapy Designations

Merck and Bristol-Myers Squibb are in danger of losing the breakthrough therapy designation for their hepatitis C drugs, in a first-ever move that could extend both drugs’ review times.

In its letters to the companies, the agency cited the recent approvals of Gilead Sciences’ Sovaldi (sofosbuvir) and Harvoni (sofosbuvir/ledipasvir) and AbbVie’s Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets copackaged with dasabuvir tablets) to treat genotype 1 hepatitis C.

The BMS drug in question is Daklinza (daclatasvir), which won EU approval in August. An NDA for the drug is pending. Merck had planned to file an NDA for its grazoprevir/elbasvir combination in the first half of this year and says the FDA’s move is not likely to change that.

Both companies now have the opportunity to provide the FDA with additional information showing their drugs should retain breakthrough status, FDA spokesman Stephen King said.

Should the revocations stand, they will most likely to affect the drugs’ review times, since a loss of breakthrough therapy status would also mean loss of priority review privileges. — Lena Freund