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Merck & Co. said the U.S. Food and Drug Administration will rescinded a special designation meant to get its experimental hepatitis C treatment to agency review faster.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