The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended seven medicines for approval, including one orphan medicine, at its January 2018 meeting25.
The seven new drugs recommended for approval are:
1. Hemlibra (Emicizumab) - First-in-class medicine to prevent bleeding in Haemophilia a patients with inhibitors
The EMA's CHMP has recommended granting a marketing authorization for Hemlibra (emicizumab)26, a first-inclass medicine to prevent bleeding or reduce the frequency of bleeding episodes in patients of all ages with Haemophilia A with factor VIII inhibitors.
Haemophilia A is an inherited bleeding disorder caused by lack of a clotting protein called factor VIII and mainly affects males. Patients with Haemophilia A are usually treated with factor VIII medicines, which replace the missing clotting protein and help control and prevent bleeding. However, the body may develop inhibitors (antibodies) as a reaction to these medicines. The inhibitors reduce the effect of medicines; hence, bleeding is no longer controlled. The development of inhibitors is the most severe treatment-related complication of Haemophilia A because it makes it difficult to manage the disease. Current treatment alternatives in patients with Haemophilia A who develop inhibitors are time-consuming and often burdensome, particularly for children, and they are also not effective in all patients. There is therefore, an unmet medical need for more convenient and effective treatment option.
Hemlibra is the first monoclonal antibody to be recommended for use in patients with Haemophilia A with inhibitors - an area of medicine where no new medicines have been made available in last 20 years. It works by mimicking the coagulation function of factor VIII. The treatment is given weekly via a subcutaneous injection, making it more convenient compared to bypassing agents (medicines that bypass factor VIII), which are the current standard of care but which require frequent, prolonged administration by infusion (drip). The CHMP reviewed the application for Hemlibra under its accelerated assessment procedure, which allows the speeding up of patients' access to medicines that address unmet medical needs.
The applicant for Hemlibra is Roche.
Download >> European Medicines Agency (EMA) Recommends Approval Of Seven Medicines In Its January Meeting
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