(Reuters) – Roche said on Thursday U.S. regulators approved its hemophilia A drug Hemlibra, expanding its use in nearly all patients, as the Swiss drugmaker pushes deeper into diseases beyond cancer to replace revenue from older, patent-expired drugs.
FILE PHOTO: The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann/File Photo
The U.S. Food and Drug Administration cleared Hemlibra for adults, children and newborn, and is the only preventive treatment for hemophilia A patients with and without factor VIII inhibitors.
Factor VIII is a protein that helps blood to clot.
The injectible medicine had previously been approved in the United States and Europe for those who had developed resistance, called inhibitors, to older treatments.
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The wholesale acquisition cost (WAC) per vial of Hemlibra has not changed since the initial FDA approval last year, the company said.
For a patient suffering from hemophilia A and who is of average weight (63.4 kg), the annual WAC of Hemlibra is about $492,000 per year, following the initial first-year dose that costs an additional $38,000.
The WAC per vial is the same for hemophilia A patients with and without factor VIII inhibitors.
Hemophilia is a rare disease, affecting only about 20,000 people in the United States and roughly 400,000 around the world, though many sufferers in poorer countries do not have access to the newest drugs.
Reporting by Saumya Sibi Joseph in Bengaluru and John Miller in Zurich; Editing by Shounak Dasgupta