Roche Granted Priority Review by FDA for Hemophilia Drug

By Sonia Amaral Rohter Features Dow Jones Newswires

Roche Holding AG (ROG.EB) on Thursday said the U.S. Food and Drug Administration granted priority review to its treatment for hemophiliacs, potentially bringing the product to market sooner than expected.

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Granting priority review means the FDA will make a decision on approval within six months. The regulator gave emicizumab priority review after the treatment showed positive results in phase III trials.

Emicizumab is designed to treat hemophilia A, an inherited disorder in which a person's blood does not clot properly.

"Results ... showed that emicizumab has significant potential to help people with hemophilia A with inhibitors, who face major challenges in preventing and treating bleeds," Roche Chief Medical Officer Sandra Horning said. "We are working with the FDA to hopefully bring this new prophylactic treatment option to the hemophilia A inhibitor community as soon as possible."

According to the U.S. Centers for Disease Control and Prevention, hemophilia occurs in about 1 of every 5,000 male births and affects around 20,000 males in the U.S.

Write to Sonia Amaral Rohter at sonia.amaralrohter@dowjones.com

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(END) Dow Jones Newswires

August 24, 2017 04:42 ET (08:42 GMT)