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Roche’s Hemlibra gets speedy FDA review for wider use

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ZURICH: Roche’s 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 company’s 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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(Reporting by John Miller, editing by John Revill)

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Ruby Khatun

Ruby Khatun joined Medical Dialogue as Reporter in 2016. She covers all the business news in different categories. She also covers all the updates in Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a post graduate from Jamia Hamdard. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Source: REUTERS
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