- The European Commission approves Alexion Pharmaceuticals' (NASDAQ:ALXN) Kanuma (sebelipase alfa) for long-term enzyme replacement therapy in patients with lysosomal acid lipase deficiency (LAL-D), an ultra-rare genetic, chronic and progressive disorder which leads to multiple organ damage and premature death. It affects ~1 in 350K newborns.
- The company will launch Kanuma in Germany in October. Negotiations regarding reimbursement are in process in each of the major European countries.
- Alexion obtained to rights to Kanuma via its acquisition of Synageva BioPharma in May.
- Previously: Europe's CHMP adopts positive opinion supporting approval for two Alexion enzyme replacement therapies (June 26)
- Previously: Alexion Pharma takes out Synageva BioPharma for $230 per share (May 6)
Alexion Pharma's Kanuma cleared in the EU for ultra-rare inherited metabolic disorder
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Alexion Pharmaceuticals, Inc. |