Blood cells (Image: NIH) (Image: NIH)

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.

While older treatments like Shire’s Feiba require intravenous infusions as often as every couple days, Hemlibra can be injected anywhere under the skin weekly, every two weeks, or monthly. Annual sales will probably reach $2.6 billion by 2022, according to eight analysts surveyed by Bloomberg.

Hemlibra first won regulatory approval in the U.S. last year and in Europe this year for patients who had few treatment options because they developed resistance to Factor VIII therapy. Shire in August failed to persuade a U.S. judge to force the drug off the market, saying it infringes on a patent and unfairly steals sales from its own treatments.

For an average weight person with hemophilia A, about 140 pounds, the annual wholesale acquisition cost of Hemlibra is approximately $492,000 per year following the initial first-year loading dose, which is an additional approximate $38,000, Roche said. The cost per vial is the same for people with hemophilia A with and without resistance to current treatments, the company said.

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