Bristol-Myers Squibb Co. said a hepatitis C drug will lose a special designation from U.S. regulators that may have led to faster market approval.
Merck & Co., the second-biggest U.S. drugmaker, said Feb. 4 that the Food and Drug Administration was planning to rescind the same status for one of its experimental hepatitis C therapies, citing the availability of other approved drugs.
Hepatitis C treatment has been transformed in recent years as Gilead Sciences Inc. and AbbVie Inc. gained approval for more convenient medications that can cure the disease in as little as eight weeks with fewer side effects than older therapies. The drugs come with hefty price tags that have drawn criticism -- for example, Gilead’s Harvoni costs $94,500 for a 12-week course of treatment.
For more details, go to: http://www.bloomberg.com/news/articles/2015-02-06/bristol-myers-hepatitis-c-drug-to-lose-special-status-from-fda