US FDA approves Bayer's haemophilia therapy Kovaltry

The US Food and Drug Administration approved Bayer AG's therapy for the most common form haemophilia, the company said yesterday, about three weeks after clearance in Europe.

With Kovaltry, bleeding in patients is reduced when infused prophylactically two or three times per week. The therapy was approved by the European Commission on 22 February.

Haemophilia is caused due to a malfunctioning gene that regulates the body's clotting mechanism and leaves people with haemophilia susceptible to spontaneous bleeding as also severe bleeding following injuries or surgery.

The disease has no cure and patients require frequent injections of blood clotting proteins that could cost up to $300,000 a year for a single patient.

According to a Bayer spokeswoman, the company could not specify a price for Kovaltry. She added, however, that it had already captured the second-largest share of the hemophilia A market in the US.

The German drugmaker's established haemophilia A therapy, Kogenate, brought in global sales of about €1.15 billion last year.

Kovaltry would enter a crowded market of drugs having varying dosing schedules including those from Baxalta Inc, which was under acquisition by Shire Plc, Pfizer Inc, Biogen Inc and Novo Nordisk A/S.

The drug was made and tested at Bayer HealthCare's Berkeley campus.

For Bayer, Kovaltry was meant to be a value-adding extension of its hemophilia pipeline and not an outright replacement for Kogenate, management had said.

Hansjoerg Duerr, Bayer Hematology's head of global strategic marketing said in an interview with FiercePharmaMarketing last month, that the German drugmaker was 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.