FDA Panel To Review Two Proposed Diabetes Drugs
March 09 2009 - 3:22PM
Dow Jones News
A U.S. Food and Drug Administration panel will review two
proposed drugs to treat Type 2 diabetes next month.
According to a meeting notice posted on the FDA's Web site
Monday, the FDA's Endocrinologic and Metabolic Drugs Advisory
Committee will discuss Bristol-Myers Squibb Co.'s (BMY) saxagliptin
tablets on April 1 and Novo Nordisk Inc.'s (NVO) liraglutide
injection on April 2.
Saxagliptin, which is similar to Merck & Co.'s (MRK)
diabetes drug Januvia, is also being developed with AstraZeneca
Inc. (AZN).
The agency is expected to look closely at both treatments to see
if they boost the risks of heart attacks and strokes. The drugs are
designed to lower blood glucose or blood-sugar levels in people
with diabetes.
In December the FDA issued a new guidance document that
recommended more stringent clinical trials for diabetes drugs to
better assess heart-attack and stroke risks. In a change that was
effective immediately, the agency said studies should "demonstrate
that new antidiabetic therapies do not increase cardiovascular risk
in comparison with existing therapies."
FDA guidance documents aren't binding, but the agency can refuse
to approve drugs that don't meet the recommendations. Applications
for saxagliptin and liraglutide were submitted to the FDA before
the new guidelines on diabetes clinical studies were released so
it's unclear whether the FDA will require more data to be submitted
for the drugs.
The FDA recommended diabetes clinical studies include older and
sicker patients at higher risk of having a heart attack or stroke
and that they be followed for as many as two years rather than
three to six months.
Saxagliptin falls into a class of drugs known DPP-4 inhibitors.
DPP-4 inhibitors work by increasing the level of so-called incretin
hormones in the body that help lower blood-glucose levels. So far
the only DPP-4 drug on the U.S. market is Merck's Januvia.
Liraglutide is a long-acting form of a hormone known as GLP-1
that triggers the release of insulin in the body, which is needed
to properly digest and use sugar from food. That drug falls into a
class of drugs known as incretin mimetics and is similar to Byetta,
by Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly & Co.
(LLY), which is injected twice daily. Liraglutide is designed to be
injected once daily.
About 23 million Americans have Type 2 diabetes, a disease
characterized by high blood-glucose levels that result from the
body's inability to use insulin. Type 2 diabetes is linked with
obesity, poor diet and lack of exercise. Diabetes also increases
the risk of heart attacks and strokes, as well as kidney and other
health problems.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com