Alexion Pharmaceuticals, Inc. ALXN was up 5.3% after the company announced that the FDA has cleared its enzyme replacement therapy, Kanuma, for the treatment of lysosomal acid lipase deficiency (LAL-D). The company plans to make the drug commercially available from the first week of Jan 2016.
Kanuma’s label also includes a survival benefit in infants and reductions in important markers of liver disease, including liver fat content, as well as significant improvements in lipid parameters in children and adults.
We note that earlier this year, Kanuma was approved in the EU as a long-term enzyme replacement therapy in patients suffering from LAL-D. The company is working on reimbursement processes with health care authorities in all of the major European countries.
Alexion has also submitted a new drug application for Kanuma to the Japanese Ministry of Health, Labour and Welfare. Moreover, Kanuma enjoys Breakthrough Therapy designation for the treatment of LAL-D in infants in the U.S. Along with this approval, the FDA issued a Rare Pediatric Disease Priority Review Voucher, which grants priority review to a subsequent drug application that would not otherwise qualify for priority review.
Our Take
FDA approval of Kanuma is a huge positive for the company. Increasing uptake of the drug would reduce the company’s dependence on Soliris for growth. Kanuma is the first approved treatment in the U.S. for patients suffering from LAL-D, indicating an untapped market for the drug.
Alexion carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK, Actelion Ltd. ALIOF and Baxalta Incorporated BXLT. While Anika and Baxalta sport a Zacks Rank #1 (Strong Buy), Actelion carries a Zacks Rank #2 (Buy).
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