Roche Leads Pipeline NewsBy
A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Roche.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday, April 11, 2017 to Tuesday, April 17, 2017.
FDA Grants Roche’s Hemophilia A Drug Hemlibra Breakthrough Therapy Designation
The US Food and Drug Administration (FDA) has granted Roche’s Hemlibra (emicizumab-kxwh) breakthrough therapy designation for patients with hemophilia A without factor VIII inhibitors.
Breakthrough therapy designation is designed to accelerate the development and review of medicines intended to treat a serious condition with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies.
Hemlibra was granted its first breakthrough therapy designation in September 2015 and was approved by the FDA in November 2017 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors. Hemlibra was also recently approved by regulatory authorities in other countries around the world, including by the European Commission in February 2018 for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors.