Roche's Hemophilia A Drug Gets Breakthrough Status in U.S.
Roche Holding RHHBY announced that ACE910 has received Breakthrough Therapy status from the FDA for the prophylactic treatment of patients aged 12 years or above, who are suffering from hemophilia A with factor VIII inhibitors.
We note that the FDA grants Breakthrough Therapy designation to candidates, which show early evidence of a significant improvement over available therapies for serious diseases, to accelerate their development and review process. Breakthrough Therapy status for ACE910 is based on promising results from two studies – a phase I study on prophylactic treatment (administered weekly as a subcutaneous injection) with ACE910 in severe hemophilia A patients and a phase I/II extension study on the same patient population.
Roche intends to initiate a phase III study on ACE910 for hemophilia A patients with factor VIII inhibitors by the end of 2015. Additionally, a phase III study on hemophilia A patients without inhibitors and a pediatric study for hemophilia A are expected to start in 2016.
According to the Centers for Disease Control and Prevention, every year, nearly 400 babies are born with hemophilia across the world. This shows that there is an unmet need for new therapies for the disease. We note that Biogen’s BIIB Eloctate is already approved for the treatment of hemophilia A.
Interestingly, this is the fourth time in 2015 that Roche has received the Breakthrough Therapy designation for its candidates. Earlier this year, the company received Breakthrough Therapy status for MPDL3280A for PD-L1-positive non-small cell lung cancer patients whose disease progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor), Actemra/RoActemra for systemic sclerosis and venetoclax for relapsed/refractory chronic lymphocytic leukemia with 17p deletion. Overall, the company has been granted Breakthrough Therapy status in nine instances for its products.
Roche carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Gilead Sciences Inc. GILD and Regeneron Pharmaceuticals, Inc. REGN. Both carry a Zacks Rank #1 (Strong Buy).
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