Bayer AG's Kovaltry, a therapy for the most common form of hemophilia has been approved by the US Food and Drug Administration (FDA) on Thursday.
Kovaltry is a therapy designed to help reduce bleeding in patients with hemophilia A by infusing prophylactically two or three times a week. European Commission also approved the Kovaltry three weeks prior to FDA approval, according to Reuters.
People with hemophilia are vulnerable to continuous bleeding because of a fault in gene that is responsible for the body's clotting mechanism. Hemophilia also makes a patient suffer from severe bleeding after a surgery or injury.
Kovaltry does not have a specific price yet according to Bayer's spokesperson. However, Kovaltry already had the second largest share of the market for hemophilia A in the U.S. Kogenate, another Bayer AG's known therapy for hemophilia A had a global sales of about $1.3 billion last year.
Kovaltry will be entering an already crowded market where products with different dosing schedules exist. These include Baxalta Inc, which is being acquired by Novo Nordisk A/S, Shire Plc, Biogen Inc and Pfizer Inc. However, Alnylam Pharmaceuticals Inc and Roche Holding AG, which promise a more convenient therapy (once a month regimen), could get into the market by 2017.
According to Fierce Biotech, Kovaltry works by replacing factor VIII, a key coagulation protein. It helps the patient's blood to normally clot alleviating the continuous bleeding that characterizes the disease. Kovaltry decreased the rate of annual bleeding in children and adults with hemophilia, Bayer said.
Kovaltry is an addition to Bayer's hemophilia pipeline and not a replacement to Kogenate, said the management. Bayer is taking "a portfolio strategy" in hemophilia said Hansjoerg Duerr, Bayer Hematology's head of global strategic marketing.
"We really want to enable a full spectrum at the end of factor VIII products to cover the needs of the patient and give the doctor different ways of managing the specific needs of a patient," Duerr said.
