Alexion's Strensiq and Kanuma Get Positive CHMP Opinions - Analyst Blog
Alexion Pharmaceuticals, Inc. ALXN announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has rendered positive recommendations relating to the marketing authorization of Strensiq (asfotasealfa) and Kanuma (sebelipasealfa).
Alexion is looking to get Strensiq approved as a long-term enzyme replacement therapy in patients suffering from pediatric-onset hypophosphatasia to treat the bone manifestations of the disease. Approval is being sought for Kanuma as a long-term enzyme replacement therapy in patients suffering from lysosomal acid lipase deficiency.
Final decision on both Strensiq and Kanuma is expected in the third quarter of 2015. The European Commission generally takes the CHMP’s opinion into account while reviewing candidates. With the CHMP issuing a positive opinion, we believe chances of Strensiq and Kanuma gaining EU approval are high.
Both Strensiq and Kanuma are currently under regulatory review in the U.S. The FDA has granted Breakthrough Therapy designation to the candidates. Alexion has also submitted new drug applications for Strensiq and Kanuma to Japan’s Ministry of Health, Labour and Welfare.
Our Take
We are pleased with the pipeline progress at Alexion. Strensiq will provide a treatment option to patients suffering from hypophosphatasia considering that there is currently no approved treatment for the disease. There are currently no therapies approved for the treatment of lysosomal acid lipase deficiency too, indicating an untapped market for Kanuma as well.
Approval of the candidates would reduce the company’s dependence on Soliris, its sole marketed product. The product is approved in the U.S., EU, Japan and other countries for the treatment of patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Alexion is also developing Soliris for other indications.
Alexion carries a Zacks Rank #3 (Hold). Better-ranked stocks in the health care sector include Valeant Pharmaceuticals International, Inc. VRX, AmerisourceBergen Corporation ABC and Acorda Therapeutics, Inc. ACOR. While Valeant carries a Zacks Rank #1 (Strong Buy), AmerisourceBergen and Acorda hold a Zacks Rank #2 (Buy).
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