FDA approves Bayer haemophilia A drug Kovaltry

pharmafile | March 17, 2016 | News story | Research and Development, Sales and Marketing Bayer, FDA, approval, drug, drug approval, haemophilia, haemophilia a, kovaltry, viii compound 

Bayer (ETR:BAYN) has received approval from the US Food and Drug Administration (FDA) for Kovaltry (octocog alfa), an unmodified, full-length factor VII compound for the treatment of haemophilia A in children and adults.

This approval follows the results from the LEOPOLD (Long-term efficacy open-label program in severe haemophilia A disease) clinical trials. Sanjay P Ahuja, MD, an investigator on the LEOPOLD trial highlights, “In the LEOPOLD trials, Kovaltry reduced bleeding episodes in patients with haemophilia A when infused twice to three times per week with routine prophylaxis. Kovaltry may offer appropriate patients a twice-weekly prophylaxis dosing option.”

Haemophilia A is a largely inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. It is the most common type of haemophilia and is characterised by prolonged or spontaneous bleeding, particularly in the joints, muscles or internal organs.

Dario Mirski, MD, Bayer’s senior vice president and head of medical affairs for the Americas, indicates: “Bayer has been committed to providing treatments for haemophilia A for more than 20 years. We’re proud to have used that knowledge to develop Kovaltry.”

The drug has already received approval in Europe and Canada, with an application already submitted in Japan, also.

Val Bias, CEO of the National Hemophilia Foundation, adds: “Haemophilia care has changed significantly in recent years, but we have a long way to go to help those living with haemophilia. It is vitally important that people are able to choose from a range of treatments, and we applaud Bayer for bringing forth new product options to help people manage their disease.”

Sean Murray

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