Biogen to launch Spinraza in Japan soon

Seven months after filing the new drug application in Japan, US biotech major Biogen (Nasdaq: BIIB) received approval from Japan’s Ministry of Health, Labor Welfare (MHLW) for its orphan drug Spinraza (nusinersen) to treat infantile-onset spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent Wang Fangqing.
“We expect to launch Spinraza in Japan as soon as in September, “a spokesperson at Biogen Japan told The Pharma Letter. Right now, she added, the drug is going through the pricing process at Japan’s MHLW, which is likely to be completed by the end of August.

Biogen Japan will import the drug from Italy, rather than manufacturing it on its own, according to the company.

A rare disease, SMA affects 1 to 2 children out of 100,000 children under 18 months in Japan, according to the nation’s Intractable Diseases Information Center. In 2015, there were 874 SMA patients in the country. There are no other approved drugs for SMA in Japan.