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Bayer gets first approval for Kogenate upgrade Kovaltry

First worldwide licence for the haemophilia treatment

Bayer has been granted EU approval for Kovaltry, a haemophilia treatment that expands the company's big-selling Kogenate franchise.

Kovaltry (octocog alfa; BAY 81-8973) - which will be sold as Iblias in some markets - is a new plasma-free recombinant Factor VIII product that does not use components of animal or human origin. It has been approved for patients of all ages with haemophilia A.

This is the first approval for Kovaltry worldwide, although it has been submitted for approval in most other major markets, including the US and Canada.

In the pivotal LEOPOLD clinical trial, Kovaltry demonstrated control of bleeds - as well as protection from bleeds - when used prophylactically either two or three times per week. Kogenate is typically given three times a week, so Kovaltry offers a slight dosing advantage to its parent product, which brought in sales of around €870m in the first nine months of 2015.

Bayer needs to round out its franchise, because while Kogenate is still growing it is facing stiffer competition from new rivals, notably Biogen's Eloctate, which can be dosed once a week and has been tipped to become a $1.5bn product. Meanwhile, there are other long-acting Factor VIII products in the pipeline from the likes of Baxter and Novo Nordisk.

Bayer is also working on a longer-acting Factor VIII product - damoctacog alfa pegol (BAY 94-9027) - that could potentially offer dosing just once a month but is not due for filing until the middle of next year. The company sees Kovaltry as a stepwise improvement that keeps it competitive in the marketplace as it gears up for damoctacog's launch.

"Haemophilia treatment has advanced considerably over the past decades; however, there is more that can be done to improve patients' quality of life", commented Johannes Oldenburg, director of the Institute of Experimental Hematology and Transfusion Medicine at University Clinic Bonn.

"The demonstrated efficacy of two and three times per week prophylactic treatment provides the flexibility to tailor the treatment to the specific need of each person affected by haemophilia A."

Article by
Phil Taylor

23rd February 2016

From: Regulatory



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