(Reuters) – Bayer AG’s long-acting treatment for hemophilia A has won a recommendation from a European Medicines Agency (EMA) panel for the treatment of the rare genetic disorder in which blood does not clot easily.
While final approvals are up to the European Commission, it generally follows recommendations from the Committee for Medicinal Products for Human Use (CHMP) and endorses them within a couple of months.
The benefits of Jivi, chemically known as damoctocog alfa pegol and available as a powder and solvent for solution for injection, are its ability to prevent and control bleeding when used on demand and during surgical procedures, CMPH said.
The U.S. Food and Drug Administration last month approved the injection for previously treated patients and adolescents aged 12 years or older, judging it helped replace the reduced or missing protein, factor VIII, required to form blood clots.
The treatment was also approved for Hemophilia A in Japan on Friday.
Hemophilia A patients repeatedly experience bleeding in muscles, joints or other tissues, which can result in chronic joint damage over time, and is mainly seen in males.
Bayer has existing factor VIII treatments, Kogenate and Kovaltry, which had combined sales of 967 million euros in 2017.
The class of drugs, already crowded by competitors seeking a share of the hemophilia treatment space, is facing a major threat from Roche’s new drug Hemlibra.
Most of the existing treatments are based on factor replacement therapies, notably from Shire as well as Sanofi , which earlier this year bought U.S. hemophilia specialist Bioverativ.
Jivi can be administered up to five days a week, allowing physicians to adjust the dosing regimen according to the patient’s needs.
Reporting by Noor Zainab Hussain in Bengaluru