Novo Nordisk’s Victoza for Diabetes Wins U.S. Backing (Update2)

Jan. 25 (Bloomberg) -- Novo Nordisk A/S, the world’s largest maker of insulin, won U.S. Food and Drug Administration approval for its diabetes drug Victoza after safety concerns delayed the agency’s decision by about 10 months.

The FDA cleared the daily shot, also known as liraglutide, for use with older pills to control blood sugar levels, the agency said today in a statement. The drug will carry a warning about pancreatitis, an inflammation of the pancreas also seen with Byetta, a twice-daily rival shot from Indianapolis-based Eli Lilly & Co. and Amylin Pharmaceuticals Inc. of San Diego.

Victoza may generate $750 million in annual sales by 2015 for the Bagsvaerd, Denmark-based company though side effects such as nausea limit more widespread use of the medicine, said Jack Scannell, a Sanford C. Bernstein Ltd. analyst in London. More than 20 million Americans have diabetes, caused when the patient doesn’t have enough of the hormone insulin used to convert blood sugar to energy. Victoza won European clearance in April.

“There is a good chance it will be a competitive drug and it’s the first to the market to rival Byetta,” Scannell said in a telephone interview before the FDA announcement. “Victoza appears to be a rather more tolerable drug and it has a better real-world efficacy,” he said, based on discussions he’s had with doctors in Germany where both medicines are sold.

Post-Market Studies

Regulators said Victoza shouldn’t be used as a first-line treatment for diabetes until additional studies are completed assessing a potential risk of cancer after thyroid tumors were seen in animal studies. An FDA advisory committee was split during an April review on whether the potential cancer risk should preclude the drug’s approval. The FDA was originally expected to rule on Novo Nordisk’s marketing application for Victoza by the end of March 2009.

Novo Nordisk is required to study the cardiovascular safety of the drug and conduct a five-year review using a database to evaluate “thyroid and other cancer risks as well as risks for seriously low blood glucose levels (hypoglycemia), pancreatitis, and allergic reactions,” the agency said in its statement.

The company expects the treatment to be on the U.S. market within weeks, Novo Nordisk said in a statement.

Approval “represents a major advancement in the treatment of Type 2 diabetes and is an important milestone for Novo Nordisk that follows the recent approval in Japan and the ongoing successful launch in Europe, Chief Executive Officer Lars Soerensen said in the statement. Victoza may generate in excess of $1 billion in revenue annually by 2012, Soerensen said in an earlier interview.

Newer Drugs

Liraglutide belongs to a newer class of diabetes drugs that imitate a hormone called GLP-1 and stimulate the pancreas to produce more insulin after meals. Lilly and Amylin are working on a once-weekly form of Byetta. Swiss drugmaker Roche Holding AG also has a once-a-week GLP-1 inhibitor known as taspoglutide in development.

An estimated 23.7 million Americans have diabetes, and the number is expected to almost double to 44 million in the next quarter century as obesity rates skyrocket, a study published in Diabetes Care found last month. Most people have the Type 2 form linked to being overweight or inactive. Diabetes drugs were the fourth-best selling medications in 2008, with $27 billion in global sales, according to IMS Health, a Norwalk, Connecticut- based company that tracks prescription trends.

Rare Tumors

The FDA advisory panel’s discussion in April focused on medullary tumors, a rare and dangerous type of thyroid cancer seen in mice and rats given liraglutide in preclinical studies. FDA staff said the data raised safety questions because no approved medicines are known to cause these tumors in two different animal species. The panel members disagreed whether the risks were “manageable” and should be examined further.

Novo Nordisk also is among the first companies facing tougher FDA standards for cardiovascular safety in new diabetes drugs. The standards were implemented in December after GlaxoSmithKline Plc’s Avandia was linked to heart attacks after eight years on the market. The agency’s advisory panel voted 8-5 that the liraglutide data ruled out “unacceptable excess” cardiovascular risks.

Those concerns will slow the development of additional diabetes drugs, Novo’s Soerensen said.

To contact the reporters on this story: Michelle Fay Cortez in London at mcortez@bloomberg.net; Catherine Larkin in Washington at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net