Merck says hepatitis C treatment to lose "breakthrough" status

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.



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