(Adds details on the drug)
Aug 18 The U.S. Food and Drug Administration
granted tentative approval for Eli Lilly and Co and
Boehringer Ingelheim's insulin injection that helps control
blood sugar levels in diabetes patients, Lilly said in a
The drug, Basaglar, is intended to provide long-lasting
blood sugar control in between meals and during the night. It is
approved for adults with type 2 diabetes and in combination with
mealtime insulin in adults and children with type 1 diabetes.
Although the drug meets all regulatory requirements for
approval, it is subject to an automatic stay order of up to 30
months because of litigation filed by Sanofi SA.
Sanofi, whose top-selling Lantus helps diabetics control
blood sugar levels, has brought a lawsuit accusing Lilly of
infringing seven patents related to insulin and devices used to
FDA cannot give final approval until the end of the 30-month
period in mid-2016, unless a court finds in favor of Lilly
About 29 million Americans and an estimated 382 million
people worldwide have type 1 or type 2 diabetes, a chronic
condition that occurs when the body does not properly produce or
use the hormone insulin.
(Reporting by Susan Kelly in Chicago and Anjali Rao Koppala in
Bangalore; Editing by Lisa Shumaker)