Japan's PAFSC backs Lilly's dulaglutide, among others, in latest round

Eli Lilly ($LLY) Japan's once-weekly glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide was recommended for approval by Japan's Pharmaceutical Affairs and Food Sanitation Council's (PAFSC's) First Committee on Drugs, an advisory panel to the health minister, following a June 5 meeting, an official said.

If fully approved, dulaglutide would be the second once-weekly GLP-1 receptor agonist sold in Japan and used to treat Type 2 diabetes, according to an industry watcher in Japan.

The committee, known as the PAFSC, had a slate of business on June 5, including for GlaxoSmithKline ($GSK) K.K.'s Botox Injection, which if approved would be the first medication to treat strabismus in Japan.

The PAFSC said as well that it supported Mitsubishi Tanabe Pharma's amyotrophic lateral sclerosis indication Racicot with orphan drug status and Sato Pharmaceutical's topical anesthetic Emla Cream used to ease pain after laser radiation therapy.

Also endorsed by the PAFSC was Alexion Pharma's ($ALXN) asfotase alfa, an orphan drug, for the treatment of hypophosphatasia as well as Asahi Kasei Pharma's collagenase clostridium histolyticum licensed from Auxilium Pharmaceuticals.

Bayer Yakuhin's Eylea (aflibercept), now approved to treat macular edema secondary to central retinal vein occlusion, will have the indication changed to macular edema secondary to retinal vein occlusion.

- here's the MHLW site in English
- and the Lilly release