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.
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Roche is pushing into new markets such as hemophilia and multiple sclerosis, disrupting existing players, as its biggest cancer medicines face competition from cheaper copycats. Hemlibra is an antibody that mimics the action of the clotting factor needed to stop bleeding, and it’s easier to administer than older treatments.
“It’s a liberating medicine,” Sandra Horning, Roche’s chief medical officer, said in a telephone interview.