Swiss Drug-maker Gets Breakthrough Therapy Designation From USFDA For Its Hemophilia Drug

The U.S. Food and Drug Administration has given drug firm, Roche, a breakthrough therapy designation for an experimental hemophilia medicine, aiming for a piece of the $11 billion hemophilia drug market. Roche prepares to separate Phase III trials in 2015 and 2016, the first in patients with hemophilia A with factor VIII inhibitors and the second for patients without inhibitors. The clinical trials represent a threat to more traditional treatments from Novo Nordisk and Baxalta, the target of a $30 billion takeover attempt by Shire.

Hemophilia A is a rare genetic disorder that prevents blood clotting. Next year the market for hemophilia medications expected to grow to $11 billion.Roche's ACE910 drug is closely watched because it could change the way the disease is treated

"FDA has granted breakthrough therapy designation for ACE910, recognizing an unmet need for patients with inhibitors and the promise of these early data," Sandra Hornung, Roche's chief medical officer, said in a statement. Last year, Roche said early data indicated encouraging reduction in bleeding rates in all patients.

Source-Medindia