Roche wins breakthrough designation from USFDA for haemoplilia medicine

Haemophilia A is a rare genetic disorder that prevents blood clotting. Patients receive lifesaving infusions of clotting factors, but development of inhibitors in many of those being treated interferes with efforts to control their bleeding.

It represents a threat to more traditional treatments from Novo Nordisk and Baxalta, the target of a $30 billion takeover attempt by Shire.

"FDA has granted breakthrough therapy designation for ACE910, recognising 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.

In 2012, U.S. regulatory changes created the breakthrough therapy designation, allowing the FDA to expedite development and review of drugs whose preliminary clinical evidence indicates substantial improvement over existing therapies.