Hemlibra closer to US approval for larger hemophilia A population

Analysts at Jeffries have predicted that Roche’s (ROG: SIX) Hemlibra (emicizumab) could generate $5 billion in annual sales – provided its use for hemophilia A is widened to the larger, non-inhibitor population.

On Tuesday, approval for that patient group in the lucrative US market moved closer with the news that the Food and Drug Administration (FDA) has granted Breakthrough Therapy deesignation for the drug for people with hemophilia A without factor VIII inhibitors.

Hemlibra is already approved in Japan, Europe and the USA as a treatment for hemophilia A patients with inhibitors to factor VIII, and has provided strong Phase III data in the non-inhibitor population, prompting this new filing.