US FDA declines to approve Shin Nippon Biomedical's migraine drug
18/01/2024 11:33
Jan 18 (Reuters) - The U.S. health regulator has
declined to approve Japan-based Shin Nippon Biomedical
Laboratories' 2395.T 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 PFE.N , Abbvie ABBV.N and Eli
Lilly LLY.N , 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.
"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)
((Puyaan.Singh@thomsonreuters.com;))