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Roche wins European approval for bleeding disorder treatment Hemlibra

It's the first new medicine in over 20 years to treat patients with inhibitors


The European Commission (EC) has approved Roche’s highly anticipated haemophilia treatment Hemlibra (emicizumab).

The rare bleeding disorder treatment, which is cleared in the EU for routine prophylaxis of bleeding episodes in people with haemophilia A, becomes the first new medicine in over 20 years to treat patients with inhibitors.

Nearly one in three people with a severe form of the disease can develop inhibitors to factor VIII replacement therapies, putting them at a greater risk of life-threatening bleeds, according to the European Haemophilia Consortium.

Commenting on the approval, Sandra Horning, chief medical officer and head of global product development for Roche, said: “We’re delighted that the European Commission has approved Hemlibra, providing people with haemophilia A with inhibitors a new medicine for the first time in over 20 years.”

Hemlibra, which is already approved in the US, is administered as a once-weekly injection, and Roche thinks this may help reduce the treatment burden for patients.

Horning added: “We believe Hemlibra has the potential to make a meaningful difference in the lives of people with haemophilia A with inhibitors, and are committed to working with EU member states to provide access to this important medicine as quickly as possible.”

The go-ahead was largely based on two clinical studies, HAVEN 1 studying the treatment in adults and adolescents 12 years and older and HAVEN 2, which evaluated the drug in children younger than 12 years of age.

Both results showed a statistical significant reduction in treated bleeds for patients on Hemlibra compared to those not taking prophylaxis.

The Swiss pharma firm will be hoping Hemlibra, which has been predicted to reach peak-year sales of $1.5bn, can help ward off the effects of biosimilar competition for some of its older drugs.

Article by
Gemma Jones

1st March 2018

From: Regulatory



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