Novartis Drug Review Extended

The FDA will take another three months to examine Galvus.
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Novartis

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said Monday that the Food and Drug Administration's review of a new diabetes drug will take another three months because the company submitted more data.

The agency is now expected to act on the drug Galvus in late February. Regulatory delays are never good news for any drug, but the delay is especially difficult for Novartis because Galvus is competing with

Merck's

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Januvia as the first drugs in a new class known as DPP-4 inhibitors.

The FDA approved the once-a-day Merck pill on Oct. 17, giving Merck an important marketing advantage. DPP-4 inhibitors are designed to control blood sugar in two ways -- stimulating the pancreas to produce more insulin and signaling the liver to produce less sugar. Insulin is the protein hormone that helps convert sugar into energy.

Both drugs are for people with type 2 diabetes, the most common version of the disease, in which the body cannot produce enough insulin or the body's cells don't respond adequately to insulin. The drugs don't work for type 1 diabetes patients, whose bodies can't produce insulin.

Shares of Novartis dropped 70 cents, or 1.2%, to $58.66 at midday.

Novartis said it had submitted additional clinical data on both short- and long-term treatments of patients. The data cover treatment solely with Galvus, as well as with Galvus and other diabetes medications that Novartis didn't identify. The company's clinical trials have included more than 7,000 people, and more studies are in progress.

Novartis said the extra information provides "further evidence confirming data submitted earlier to the FDA showing that skin findings identified in a single species during a preclinical animal study have not been seen in clinical studies with patients treated for type 2 diabetes." Some monkeys given Galvus had exhibited skin lesions in clinical tests.

Novartis also said the extra data support the company's proposed dosing regimen and indications for the drug and provides more information on the drug's risk and benefit profile.

"We are confident of the efficacy and safety of Galvus and in gaining U.S. approval," said Dr. James Shannon, head of development at Novartis' prescription drug unit, in a prepared statement. "We believe this additional information being provided to the FDA will strengthen the already robust data supporting Galvus."