European Commission approves Roche's Hemlibra for people with severe haemophilia A without factor VIII inhibitors

F. Hoffmann-La Roche Ltd / European Commission approves Roche's Hemlibra for people with severe haemophilia A without factor VIII inhibitors . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

• First medicine to significantly reduce treated bleeds compared to prior factor VIII prophylaxis, in a prospective intra-patient comparison

Only prophylactic medicine that can be given subcutaneously and with multiple dosing options

The efficacy and safety of Hemlibra has been demonstrated in one of the largest pivotal clinical trial programmes in haemophilia A

Basel, 14 March 2019 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors. Hemlibra can be used in all age groups, and can also now be used at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people with haemophilia A, including those with factor VIII inhibitors.

This approval is based on results from the pivotal HAVEN 3 and HAVEN 4 studies. In the HAVEN 3 study in people with haemophilia A without factor VIII inhibitors, Hemlibra prophylaxis led to statistically significant and clinically meaningful reductions in treated bleeds compared to no prophylaxis, and compared to prior treatment with factor VIII prophylaxis in a prospective intra-patient comparison. In the HAVEN 4 study in people with haemophilia A with and without factor VIII inhibitors, Hemlibra showed a clinically meaningful control of bleeding when dosed every four weeks.

"We are delighted that now people with severe haemophilia A without inhibitors in the EU will also have the opportunity to benefit from Hemlibra, which has been shown to significantly reduce bleeds compared to no prophylaxis and compared to prior factor VIII prophylaxis,"  said Dr Elena Santagostino, Director of the Hemophilia Unit at the Angelo Bianchi Bonomi Hemophilia and Thrombosis Centre of the Cà Granda Foundation, Maggiore Hospital Policlinico of Milan, Italy. "We are hopeful that the three different dosing options will allow people with haemophilia A and their physicians to choose the option that's right for them, based on their lifestyle and preferences."