The U.S. Food and Drug Administration (FDA) approved Bayer AG’s drug for the treatment of hemophilia A, a rare genetic disorder in which the blood does not clot normally, the company said in a statement.
The injectable drug, marketed under the name Jivi, has been approved for previously treated patients and adolescents aged 12 years or older.
Hemophilia A patients repeatedly experience bleeding in muscles, joints or other tissues, which can result in chronic joint damage over time. The disease affects about 1 in 5,000 newborn males.
Jivi can be administered up to five days a week, and allows physicians to adjust the dosing regimen according to the patient’s needs, the company said.
The approval is based on the company’s mid-stage study results, which showed that the drug was able to replace the reduced or missing protein, Factor VIII, required to form blood clots in patients suffering from hemophilia A.
Current treatments are reliant on factor replacement therapies, notably from Shire, Bayer and well as Sanofi, which earlier this year bought U.S. haemophilia specialist Bioverativ.
(Reporting by Saumya Sibi Joseph in Bengaluru Editing by Saumyadeb Chakrabarty)