Bayer wins FDA approval for a long-acting hemophilia drug

Bayer won FDA approval for a twice-a-week therapy for hemophilia A, wading into a crowded field of drugmakers angling to launch more convenient treatments for the disease.

The agency signed off on Kovaltry, a treatment that can be dosed two or three times a week in adults and every other day in children. Like Bayer's blockbuster daily treatment Kogenate, the new injection treats hemophilia A by replacing a key coagulation protein called factor VIII, helping patients' blood to clot normally and reducing the dangerous bleeds that characterize the disease. Across three clinical trials, Kovaltry improved annual bleed rates in adults and children with hemophilia, Bayer said.

Bayer will now contend with a crop of long-lasting hemophilia treatments contending to lure patients away from older therapies. Biogen ($BIIB) won approval for the long-acting factor VIII injection Eloctate in 2014, and Baxalta's ($BXLT) similar Adynovate cleared the agency in November. Meanwhile, Novo Nordisk ($NVO) is working through Phase III development with a pegylated version of its NovoEight that can be dosed every few days.

Bayer's Hansjoerg Duerr

For Bayer, Kovaltry is meant to be a value-adding addition to its hemophilia pipeline and not an outright replacement for Kogenate, management has said. In an interview with FiercePharmaMarketing last month, Hansjoerg Duerr, Bayer Hematology's head of global strategic marketing, said the German drugmaker is taking "a portfolio strategy" in hemophilia.

"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.

- read the statement