By Ransdell Pierson
March 5 Eli Lilly and Co and partner
Boehringer Ingelheim said U.S. regulators have declined to
approve their experimental diabetes drug empagliflozin, citing
previously observed problems at a facility where it would be
The drugmakers, in a joint release on Wednesday, said the
U.S. Food and Drug Administration determined that issues at the
Boehringer factory in Ingelheim, Germany, need to be resolved
before the product could be approved.
Lilly and privately held Boehringer said the FDA had not
asked for new clinical trials of the diabetes drug.
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.
The FDA issued a warning letter in May 2013 citing problems
it found at the Boehringer plant during an inspection six month
earlier. Among other issues, the FDA said it detected foreign
particles in batches of active pharmaceutical ingredients.
Boehringer said it is continuing a costly program to upgrade
systems and processes at the plant while an FDA reinspection is
The improvements include a strengthened management
structure, hiring of 200 specialists in manufacturing and
quality organizations, and an employee training program.
Alex Arfaei, an analyst with BMO Capital Markets, said he
expects the FDA to approve empagliflozin this year, and for it
to generate eventual annual collaboration revenue of $1.6
billion for Lilly.
Lilly shares were down 0.7 percent to $59.41 in afternoon
trading on the New York Stock Exchange amid a moderate downturn
for the drug sector.