Biogen to launch Spinraza in Japan soon

10 July 2017

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.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK