Novo Aims for Tresiba U.S. Approval in First Half of 2013

Novo Nordisk A/S (NOVOB) is targeting U.S. approval of its experimental diabetes medicine Tresiba in the first half of next year after obtaining the backing of an advisory panel to the Food and Drug Administration, said Mads Krogsgaard Thomsen, Novo’s chief scientific officer.

Heart risks with the medicine, also known as insulin degludec, probably aren’t enough of a concern to block its approval, a majority of the FDA advisers said yesterday. Novo Nordisk shares posted their biggest gain in two years today.

“For sure we will target working with the agency in such a way that we can get the approval in the first half next year,” Thomsen said in a telephone interview today from Novo’s headquarters in Bagsvaerd, Denmark. The FDA hasn’t informed Novo of a date it expects to complete the Tresiba review, he said.

Novo, the world’s largest insulin maker, provided sufficient efficacy and safety data to support marketing degludec for use alone or in combination with an insulin boost for blood-sugar control during meals, the panel voted 8-4 yesterday. It voted 12-0 that the company should conduct a trial to examine the cardiovascular safety of degludec, which may have higher heart risks than other diabetes treatments. The FDA isn’t required to follow the panel’s advice.

Stock Rises

Novo shares jumped 7.3 percent to 928 kroner, their steepest increase since Oct. 20, 2010, in Copenhagen trading today. The stock has risen 41 percent this year.

“Even with a positive recommendation, the commercial outlook for degludec is probably meaningfully impaired,” Tim Anderson, an analyst at Sanford C. Bernstein & Co. in New York, wrote in a report to clients after the panel meeting ended. “The panel vote was mixed, with some panelists feeling that degludec’s benefit” outweighed “risk, but others feeling the opposite.”

Novo needs Tresiba to help bridge a gap with France’s Sanofi (SAN), whose best-selling Lantus insulin last year generated 3.92 billion euros ($5 billion) in revenue. Tresiba has been approved for sale in Japan and won the backing of a European Union advisory panel on Oct. 19.

Tresiba’s potential won’t “by any means” be affected by yesterday’s FDA panel discussion, Thomsen said in the interview.

Victoza’s Tests

Novo is still conducting a post-approval cardiovascular outcomes study for another of its diabetes treatments, Victoza, “and it’s not impacting the way that anybody is seeing this product,” Thomsen said. Victoza is Novo’s biggest growth engine today.

Tresiba is a “safe” medicine, and “it is natural that we commit to do post-marketing studies based on recommendations from the FDA and their advisory committee,” he said.

Diabetes, caused by the body’s inability to sufficiently produce the insulin needed to convert blood sugar into energy, affects almost 26 million Americans, or 8 percent of the U.S. population, according to the Centers for Disease Control and Prevention. Diabetes treatments have come under closer scrutiny since sales of GlaxoSmithKline Plc (GSK)’s Avandia were restricted because of increased heart attack risk.

‘Concerning Signal’

“We have a concerning signal, but it’s not of a degree that we insist that this drug be abandoned and not be approved, but it’s of sufficient degree that we insist more patients be looked at,” said Ed Hendricks, a panelist and medical director at the Center for Weight Management in Roseville, California.

Novo proposed conducting a trial to assess the cardiovascular risk of Tresiba after approval. The study would include 7,500 patients and last five years. The panel didn’t vote on whether the tests should take place before or after the drug is allowed on the market.

“It is usually impractical to require long-term definitive studies prior to approval,” said Kenneth Burman, acting panel chairman and chief of the endocrine section at Washington Hospital Center.

U.S. regulators earlier this year extended Tresiba’s review period. The FDA originally planned to make a decision on the medicine by July 29. It postponed the date to Oct. 29, before deciding for a Nov. 8 advisory panel. Novo isn’t expecting another so-called FDA action date for Tresiba, Thomsen said.

The agency probably will delay approval of the insulin by a further six to 12 months, given the issues raised by the panel, Seamus Fernandez, an analyst with Leerink Swann & Co. in Boston, said in note to clients.

“It was a vivid, constructive debate,” Thomsen said about the panel meeting. “This is how the FDA advisory committee works. They are mandated to stress-test” the benefits and risks of new products.

To contact the reporter on this story: Albertina Torsoli in Paris at atorsoli@bloomberg.net

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

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