Roche Wins Right to Sell Specialty Drug to Most U.S. Hemophilia Patients

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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