UPDATE:FDA Sees Few Cardiovascular Events In Liraglutide Trials
March 31 2009 - 11:35AM
Dow Jones News
The Food and Drug Administration said Tuesday it saw a low
cardiovascular event rate in clinical studies of liraglutide, a
proposed diabetes drug being developed by Novo Nordisk Inc. (NVO),
but raised concerns about a small number of patients who developed
a type of thyroid cancer during clinical studies.
Liraglutide, a drug being developed to treat type-2 diabetes,
faces a review by an outside panel of medical experts Thursday. The
panel will be asked to vote on questions about safety and the
outcome of those votes will amount to a recommendation about
whether it thinks the agency should approve the product. The FDA
usually follows its panels' advice but is not required to.
The FDA has been concerned about cardiovascular side effects of
diabetes drugs since a research paper was published in 2007 linking
GlaxoSmithKline PLC's (GSK) widely-used Avandia to increased risk
of heart attack. The agency issued new guidance in December
requiring drug makers to conduct more-stringent clinical trials for
type-2 diabetes drugs to better assess heart-attack and stroke
risks. The application for liraglutide was submitted last May
before the guidelines were issued.
In documents prepared for the panel meeting that were released
Tuesday, the FDAsaid while it saw a low cardiovascular event rate
in clinical studies of liraglutide, it will ask the panel for
advice on whether it "permits a reliable assessment of clinical
safety."
The agency is also asking the panel about the development of
certain thyroid tumors that were seen in rodent studies and whether
they are relevant to humans.
The agency said in clinical studies there were five patients who
developed papillary thyroid carcinoma among patients taking
liraglutide and one case among a patient not receiving the
drug.
The FDA said most of the reported thyroid cancers were "very
small." The agency also said small thyroid tumors are commonly
found in the general population.
Novo Nordisk, in a briefing document released by the FDA, said
the thyroid findings may be "ascertainment bias." In at least one
clinical study all patients underwent thyroid ultrasounds.
The company has proposed conducting a large post-marketing trial
that would study cardiovascular outcomes as well as other potential
side effects.
Novo Nordisk said liraglutide was effective at lowering
blood-glucose levels compared to other diabetes drugs looked at in
clinical studies. The company also said the drug helped some
patients lose weight and lowered blood pressure.
Type 2 diabetes, which affects 23 million Americans, is
characterized by high blood-glucose levels that result from the
body's inability to use insulin.
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. The drug is designed to
be injected once daily. It 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.
Amylin, Lilly and Alkermes Inc. (ALKS) are working on a form of
Byetta that would be injected only once weekly, and the companies
are expected to file a new drug application with the FDA by the end
of June.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com