Merck & Co on Wednesday said U.S. regulators intend to rescind the “breakthrough therapy” designation for its combination treatment for hepatitis C because other new drugs are available, a decision that could delay approval of the Merck product by several months.
The Food and Drug Administration gives the designation to medicines it deems likely to demonstrate “substantial improvement” over existing drugs. The designation has hastened approval of some drugs by two to three months.
Analysts said Merck’s two-drug treatment would likely now require a standard 10-month review.
Merck, in its fourth-quarter earnings report, said it plans to discuss the matter with the FDA and still expects to seek U.S. approval in the first half of 2015. The treatment consists of a protease inhibitor called MK-5172 and a so-called NS5A inhibitor called MK-8742 that together had received the FDA’s “breakthrough therapy” designation.
In a recent mid-stage trial, Merck’s combo cured 98 percent of previously untreated patients with genotype 1, the most common and hardest to treat variant of hepatitis C. Merck said late-stage trials are now complete, and will support approval.
“Based upon data today, we believe we will be able to compete in the marketplace,” Adam Schechter, head of global human health for Merck, said in an interview.
The setback for Merck follows recent approvals of costly oral treatments for the liver disease from Gilead Sciences Inc and AbbVie Inc that have wiped out all signs of the virus in well over 90 percent of patients after eight or 12 weeks.
“The breakthrough therapy designation is meant for drugs that address an unmet medical need, but we now have two virtual cures for hepatitis C on the market” from Gilead and AbbVie, said Edward Jones analyst Ashtyn Evans.