FDA to Rescind Breakthrough Status for Merck Hepatitis Drug

Merck & Co. said the U.S. Food and Drug Administration will rescinded a special designation meant to get its experimental hepatitis C treatment to agency review faster.

It’s a rare move by the FDA. The program, called a “breakthrough designation,” lets drugmakers work closely with the agency to get experimental treatments submitted faster. Breakthrough designations are given to new treatments that represent a significant medical advance, though in the last year two companies have introduced new hepatitis C drugs that have higher cure rates and fewer side effects than older treatments.

Merck said in a statement it still plans to file in the first half of 2015 and that the FDA’s notice doesn’t change that plan. Earlier today, the company reported fourth quarter financial results and gave estimates for 2015.

Stephanie Yao, an FDA spokeswoman, declined to comment on Merck’s drug or whether it was the first time the FDA had taken back a breakthrough designation.

If approved, Kenilworth, New Jersey-based Merck’s treatment will compete against therapies from Gilead Sciences Inc. and AbbVie Inc.

Hepatitis C has become a popular therapeutic area and one in which drugmakers have been charging high prices. Gilead introduced its drug Sovaldi to the market for $84,000 for a 12-week treatment.

On Friday, AbbVie said sales of its new hepatitis C drug, while projected to be a blockbuster, would be slower than investors and analysts previously estimated.

(An earlier version of this story corrected the status of the FDA designation in the first paragraph.)

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