Roche: positive opinion from CHMP for Hemlibra
(CercleFinance.com) - Roche has announced that the CHMP recommends EU approval of Roche's Hemlibra (Emicizumab) for people with haemophilia A with inhibitors for the routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors.
The Swiss Health Group explains that this recommendation is based on two pivotal clinical studies in patients with haemophilia A with inhibitors, the Phase III "Haven I" and "Haven II" studies.
Based on this positive recommendation, obtained following an accelerated evaluation, a final decision on the approval of Hemlibra by the European Commission is due in the near future.
Copyright (c) 2018 CercleFinance.com. All rights reserved.
The Swiss Health Group explains that this recommendation is based on two pivotal clinical studies in patients with haemophilia A with inhibitors, the Phase III "Haven I" and "Haven II" studies.
Based on this positive recommendation, obtained following an accelerated evaluation, a final decision on the approval of Hemlibra by the European Commission is due in the near future.
Copyright (c) 2018 CercleFinance.com. All rights reserved.