April 2, 2009 / 9:10 PM / 10 years ago

UPDATE 3-US panel split on Novo Nordisk diabetes drug safety

* FDA will consider divided vote on tumor concerns

* Advisers find drug’s heart risks acceptable

* Company says no evidence of cancer risk to people

(Recasts, Adds FDA, company, analyst comment, shares)

By Lisa Richwine

SILVER SPRING, Md., April 2 (Reuters) - A U.S. advisory panel handed drugmaker Novo Nordisk (NOVOb.CO) (NVO.N) a split ruling on whether a proposed diabetes medicine was safe enough to come to the market.

The Food and Drug Administration’s outside experts voted 6-6 when asked if thyroid tumors found in tests of rats and mice should prevent sales of the drug, liraglutide. One panel member abstained.

The final decision now rests with the FDA. Industry analysts view liraglutide as a potential blockbuster and a key driver for Novo’s growth.

“I think (the panel vote) reflects the complexity of the issue. It shows a panel of experts who really vigorously debated this issue found it was difficult to interpret,” Dr. Mary Parks, the FDA’s director of metabolism and endocrinology drugs, told reporters.

Novo Nordisk officials told the committee there was no evidence liraglutide would cause thyroid tumors in humans, but panel members said the company had not presented a convincing case to dismiss the concern entirely.

“I just don’t think we have enough data to be reasonably confident of the safety in humans for long-term use,” said Dr. Peter Savage, a senior adviser at the National Institutes of Health.

Nearly 24 million Americans have diabetes, the U.S. government estimates. Most cases are type 2 diabetes, which is linked with obesity, poor diet and lack of exercise. Serious complications include heart attacks, amputations and blindness.

Diabetics often take multiple drugs to control their blood sugar for years.

Liraglutide’s backers on the panel said they saw advantages over other diabetes treatments, including weight loss and once-a-day dosing, and the cancer concern could be addressed in part through screening tests to catch problems early.

“I would hate for us to miss out on this new medicine that seems to have an excellent benefit profile,” said Dr. Eric Felner, an endocrinologist at Emory University.

Some panelists who voted that the tumors were worrisome said they were optimistic the company could overcome the concerns with additional study.

“We only need a little longer data,” said panel chairman Dr. Kenneth Burman, chief of the endocrine section at Washington Hospital Center.

Analyst Ira Loss of Washington Analysis said he thought liraglutide’s debut likely would be delayed but it eventually would reach the market.

The split vote “gives the FDA latitude. A few of the no’s were wishy-washy” and seemed to favor approval, he said.

Separately, the panel voted 8-5 that Novo had provided enough evidence to rule out an unacceptable risk of heart damage. Cardiac risks have emerged as a concern for diabetes drugs, and the FDA has asked manufacturers to analyze if their medicines raise the chances of heart attacks, strokes or other problems.

The Danish drugmaker said it would work with the FDA to address the panelists’ concerns.

“We remain convinced that liraglutide has a positive benefit-risk profile and represents an important advance for people with type 2 diabetes,” Mads Krogsgaard Thomsen, Novo’s executive vice president and chief science officer, said in a statement.

The panel’s decision “is not expected to significantly impact” financial expectations for 2009 that were provided in January, Novo’s statement said.

Liraglutide belongs to the GLP-1 class of injectable drugs that stimulate insulin release when glucose levels become too high. If approved, it would provide competition for Amylin Pharmaceuticals Inc’s AMLN.O GLP-1 drug Byetta.

Liraglutide’s proposed brand name is Victoza.

Consensus forecasts for liraglutide have come down to around $1.3 billion to $1.5 billion, according to analysts at Citigroup, nearer the brokerage’s own cautious prediction of $1.2 billion in 2015.

Novo Nordisk shares fell 4.3 percent to close at $47.92 on the New York Stock Exchange. Some of the panel votes came after U.S. trading closed. Novo shares gained 8 cents in after-hours trading. (Reporting by Lisa Richwine; Editing by Bernard Orr and Marguerita Choy)

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