US FDA declines to approve Shin Nippon Biomedical's migraine drug

[January 18, 2024]  (Reuters) - The U.S. health regulator has declined to approve Japan-based Shin Nippon Biomedical Laboratories' treatment for acute migraine late on Wednesday, citing manufacturing concerns.

Japan-listed stock of Shin Nippon (SNBL), which acquired the drug through its purchase of Satsuma Pharmaceuticals in April last year, was down 12.2% at 1,721 yen ($11.64) at Thursday's close.

SNBL said the complete response letter from the Food and Drug Administration (FDA) did not indicate any concerns related to the data nor was there any request for additional information.

The drug had failed to help patients get rid of their migraine and did not meet other key goals when compared with a placebo in a late-stage study in November 2022.

However, SNBL had been hopeful of approval based on a separate late-stage study that showed the drug provided pain relief within two hours of treatment in more than a third of the cases.

The FDA's decision further pushes the timeline for Shin Nippon to enter a crowded U.S. market for migraine drugs that include treatments from Pfizer, Abbvie and Eli Lilly, among others.

The company plans to work with the FDA for re-submission of the marketing application for the drug, said Dr. Ryoichi Nagata, Chief Executive Officer of Satsuma.

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. Picture taken August 14, 2012. REUTERS/Jason Reed/File Photo

"SNBL's ownership of Satsuma is an unfortunate distraction from its main pre-clinical testing business", said Stephen Barker, analyst at Jefferies.

But the Japanese company will likely continue to spend time and money to address the FDA concern due to interest in Satsuma's pipeline, Barker added.

Migraine pain and symptoms affect 29.5 million Americans, according to U.S. government data. There were an estimated 1.1 billion people suffering from migraine worldwide in 2019.

Shin Nippon's treatment involves delivering a powdered form of dihydroergotamine, a drug initially approved to treat migraines in 1945, through a nasal spray.

($1 = 147.8400 yen)

(Reporting by Puyaan Singh and Khushi Mandowara; Editing by Krishna Chandra Eluri)

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