Japan MHLW panel names 11 unapproved/off-label drugs for fast-track reviews

A special panel at Japan's Ministry of Health, Labour and Welfare designated 11 unapproved and off-label drugs as applicable to unmet medical needs, putting them in line for fast-track review in Japan by the Pharmaceuticals and Medical Devices Agency.

The Council on Unapproved Drugs and Indications with Unmet Medical Needs on April 22 approved the drugs after receiving development requests from stakeholders such as patient advocacy groups and medical professionals in clinical or academic settings for therapies approved in countries such as the European Medicines Agency or the U.S. FDA, among others, according to a spokesperson.

Under the "sakigake" designation products can get accelerated reviews.

The drugs, 5 unapproved and 6 off-label, were listed as polyethylene glycol from Japan's Ajinomoto Pharmaceuticals, anakinra from Swedish Orphan Biovitrum, cisatracurium besylate from GlaxoSmithKline ($GSK) and AbbVie ($ABBV) as well as off-label use of valganciclovir from Mitsubishi Tanabe Pharma.

The panel also named unmet needs for the off-label use of a botulinum toxin A preparation, tolvaptan, and colchicine, according to the spokesperson, who added that the final list will be notified on the MHLW website at a later date.