Roche's Hemlibra gets speedy FDA review for wider use

From Reuters - April 16, 2018

ZURICH (Reuters) - Roches hemophilia A drug Hemlibra will get an accelerated review by U.S. regulators for use in a new group of patients, a key part of the Swiss drug companys plans to muscle in on turf dominated by rivals including Shire.

The U.S. Food and Drug Administration granted breakthrough therapy designation to the medicine to be used in people who have not yet developed resistance to conventional treatments, called inhibitors, Roche said on Tuesday. Hemlibra is already approved for people with inhibitors, though Shire is fighting Roche in court seeking to halt expanded use of the medicine.


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