Japanese approval for Kanuma in LAL-D

US drugmaker Alexion Pharmaceuticals (Nasdaq: ALXN) said on Monday that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Kanuma (sebelipase alfa) for the treatment of patients of all ages in Japan with lysosomal acid lipase deficiency (LAL-D).

Kanuma, an innovative enzyme replacement therapy (ERT), is the first therapy approved in Japan for the treatment of patients with LAL-D, a genetic and progressive ultra-rare metabolic disease in which patients suffer multi-organ damage and premature death. Alexion expects that initial patients with LAL-D in Japan will start commercial treatment with Kanuma in the third quarter of 2016.

“We are gratified that patients of all ages in Japan who suffer from LAL-D will now have the first approved therapy that addresses the underlying cause of this devastating disease,” said David Hallal, chief executive of Alexion, adding: “Importantly, the label notes the significant survival benefit in infants with LAL-D who were treated with Kanuma, as well as reductions in important markers of liver disease and significant improvements in lipid parameters in pediatric and adult patients. We look forward to working with healthcare authorities to bring Kanuma to patients with LAL-D and their physicians in Japan as quickly as possible.”