FREETOWN,
Sierra Leone – The Food and Drug
Administration has approved a new injectable diabetes drug from Eli Lilly and
Co. for adults with the most common form of the disease.
The agency on Thursday cleared the drug,
Trulicity, as a weekly injection to improve blood sugar control in patients
with type 2 diabetes, which affects more than 26 million Americans. The drug is
part of a new class of medicines called GLP-1 agonists, which spur the pancreas
to create extra insulin after meals.
Type 2 diabetes accounts for 90 percent of
U.S. cases of the disease and occurs when the body doesn't properly produce or
use the hormone insulin. Drugs to treat the disease represent a large slice of
Lilly's product portfolio, which includes the insulins Humalog and Humulin.
Indianapolis-based Lilly is counting on new
drugs like Trulicity to replace falling revenue from blockbusters like the
antidepressant Cymbalta, which is facing cheaper generic competition after the
expiration of its patent.
The FDA approved Trulicity based on six
studies in 3,342 patients that showed improvements in blood sugar control. The
drug was studied as a stand-alone therapy and in combination with other
commonly used diabetes drugs, such as metformin.
The drug will bear a boxed warning - the
most serious type - highlighting that rats tested with Trulicity had cases of
thyroid cancer, though it's unclear whether they were caused by the drug.
Lilly
will be required to conduct follow-up studies on cases of thyroid cancer, heart
problems and other potential safety issues with the drug. The FDA is also
requiring Lilly to educate doctors about the drug's various risks
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