Roche Wins U.S. Nod to Sell Hemlibra to Most Hemophilia Patients
- Drug cleared those for with no resistance to current treatment
- Price is same for patients with and without resistance
Photographer: Gianluca Colla/Bloomberg
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Roche Holding AG won U.S. regulatory approval to sell its Hemlibra medicine to the largest group of hemophilia patients, bolstering the Swiss drugmaker’s effort to branch away from cancer and further encroach on Shire Plc’s and Bayer AG’s turf.
The U.S. Food and Drug Administration on Thursday cleared the medicine, also known as emicizumab, for patients with hemophilia A who haven’t developed resistance to the current standard treatment, a category of drugs called Factor VIII replacement therapy. These people make up the biggest portion of the hemophilia market, which may be worth $12.6 billion by 2022.