Roche scores two EU approvals in haemophilia and rare autoimmune disease

pharmafile | March 15, 2019 | News story | Medical Communications EC, EU, Europe, Roche, haemophilia, rare diseases 

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

The approval comes as the EC approved Roche’s MabThera (rituximab) for the rare autoimmune disease pemphigus vulgaris (PV) marking the first major advancement in treatment fo the disease in more than 60 years.

Hemlibra, a bispecific antibody targeting factor IXa- and factor X was approved as a treatment in routine prophylaxis of bleeding episodes in severe haemophilia A patients without factor VIII inhibitors.

Meanwhile MabThera was approved as a treatment for a rare autoimmune disease which causes blistering, severe pain and even disfigurement.

On the approval of MabTherea, Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, said: “We’re pleased to bring the first biologic medicine to the more than 50,000 people in Europe suffering from pemphigus vulgaris. This MabThera approval provides a much needed new treatment that has been shown to provide higher remission rates than corticosteroids alone, which can cause debilitating side effects.”   

In discussing Hemlibra Dr Horning said: “Today’s approval is a landmark moment as Hemlibra is the first new class of treatment for people with severe haemophilia A without inhibitors in nearly 20 years. We will continue to work with EU member states, to bring this important treatment to those in need as quickly as possible.”

Louis Goss

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