New data reinforce benefit of early preventative treatment with Roche™s Hemlibra
Basel, 01 February 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission approved the expansion of the Hemlibra® (emicizumab) European Union (EU) marketing authorisation. The label will now include the routine prophylaxis of bleeding episodes in people with haemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, who have moderate disease (FVIII ?1% and ? 5%) with a severe bleeding phenotype.3 Haemophilia A affects around 900,000 people worldwide,4,5 approximately 14% of whom have a moderate form of the disease.6
As an FDA approval decision looms, Sanofi has unveiled more data from a phase 3 trial of its potential hemophilia A rival to Roche’s blockbuster Hemlibra.
CHMP recommends expansion of EU label for Hemlibra to include people with moderate haemophilia A
Interim data from phase III study presented at ASH 2022 show Hemlibra achieved meaningful bleed control in infants from birth
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced interim results from the Phase III HAVEN 7 study. The study shows Hemlibra® (emicizumab-kxwh) achieved meaningful bleed control with a favorable safety profile in infants (up to 12 months) with severe hemophilia A without factor VIII inhibitors: 77.8% of participants did not have any bleeds that required treatment and 42.6% did not have any treated or untreated bleeds at all. These results help support the use of Hemlibra in this population, in which it is already approved in many countries around the world. The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.
Sanofi has been setting itself up for a rematch against other pharmas in the hemophilia space, and thanks to the FDA, the company is now one step closer.
Hemlibra receives new approval in Japan intractable disease indication, while positive Phase III results in mild/moderate disease hemophilia A will support a planned EU filing in this setting.
Hemlibra continues to demonstrate clinically meaningful bleed control, with 66.7% of participants with moderate or mild haemophilia A experiencing zero treated bleeds at 55.6 weeks median follow-up...
Genentech`s Hemlibra emicizumab-kxwh Receives Supplemental Approval in U.S.