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Home Industry News Bayer HealthCare’s Kogenate receives backing from CHMP

Bayer HealthCare’s Kogenate receives backing from CHMP

24th December 2013

Bayer HealthCare has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has endorsed the positive overall safety profile of its haemophilia A treatment Kogenate Bayer.

The committee has completed a review of the drug and concluded that the benefits of Kogenate Bayer outweigh the risks for the treatment and prophylaxis of bleeding in previously untreated patients with haemophilia A.

It also found that current evidence did not indicate an increased risk of developing antibodies against Kogenate Bayer when compared with other recombinant or plasma-derived factor VIII products.

Following this report, Bayer HealthCare will be required to update the product's labelling to reflect the frequency of inhibitor development in previously untreated patients, as noted in the recent Rodin study.

A statement from the company said: "Bayer has closely collaborated with the relevant health authorities in this referral procedure and will continue to do so."

This comes after the firm agreed a deal to purchase Norwegian pharmaceutical company Algeta earlier this month, a move that will strengthen Bayer's oncology capabilities.ADNFCR-8000103-ID-801676019-ADNFCR

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