FRANKFURT, June 3 Eli Lilly's partner in
a diabetes alliance, Boehringer Ingelheim, said that U.S.
regulators had given it the go-ahead for a German plant after
solving quality problems, paving the way for a renewed request
for approval of a drug.
The U.S. Food and Drug Administration in March declined to
approve Lilly and Boehringer's experimental diabetes drug
empagliflozin, citing manufacturing problems at Boehringer's
headquarters, where it would be made.
Boehringer on Tuesday said it was told by the FDA that based
on a March inspection, the facility's quality management and
compliance systems were found to be acceptable again.
"This gives us the opportunity to renew our request for
approval," a company spokesman said.
The drug is a member of a new class of diabetes medicines
known as SGLT2 inhibitors, which block the kidney from
reabsorbing blood sugar, thereby spurring removal of glucose
through the urine. Recently approved similar medicines include
Johnson & Johnson's Invokana.
Analysts surveyed by Thomson Reuters Cortellis on average
expect Lilly to generate sales of more than $400 million from
the drug in 2019.
The FDA issued a warning letter in May 2013 citing problems
it found at the Boehringer plant during an inspection six months
earlier. Among other issues, the FDA said it detected foreign
particles in batches of active pharmaceutical ingredients.
(Reporting by Ludwig Burger, editing by Louise Heavens)