Baxalta receives CHMP backing for new haemophilia drug Obizur

Baxalta has announced that its new haemophilia A drug Obizur has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on the marketing authorisation of the drug, for use in the treatment of bleeding episodes in adult patients with acquired haemophilia caused by antibodies to Factor VIII (FVIII).

If approved, Obizur will become the first recombinant porcine FVIII treatment available for acquired haemophilia A, allowing physicians to monitor treatment response by measuring FVIII activity levels in addition to clinical assessments.

The therapy has been granted orphan drug designation by the European Commission, based on the classification of acquired haemophilia A as a rare disease, as well as the potential for the treatment to address an important unmet medical need.

Dr John Orloff, head of research and development and chief scientific officer at Baxalta, said: "The positive support by the European regulators reflects the value this therapy can provide to patients, and supports Baxalta's longstanding commitment to addressing unmet needs and reducing the global burden of bleeding disorders."

The company is also developing an investigational haemophilia A therapy called BAX 855, which will be marketed under the brand name Adynovate once it has been launched.