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Novo’s Tresiba wins backing of advisers despite risks

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The heart risks with Novo Nordisk A/S’s once-a-day insulin Tresiba are probably not of enough concern to block approval of the medicine, the majority of an advisory panel to the U.S. Food and Drug Administration said.

Novo (NYSE: NVO), the world’s largest insulin maker, provided sufficient efficacy and safety data to support marketing the drug known as degludec for use alone or in combination with an insulin boost for blood-sugar control during meals, the panel voted 8-4 Thursday. It voted 12-0 that Novo should conduct a trial to examine the cardiovascular safety of degludec, which may have higher heart risks than other diabetes treatments.

“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, Calif.

While the FDA isn’t required to follow the panel’s advice, the vote Thursday helps Bagsvaerd, Denmark-based Novo clear a hurdle in its race to compete with Sanofi’s best-selling Lantus insulin, which last year generated 3.92 billion euros ($5 billion) in revenue. Novo designed Tresiba as longer-lasting, higher dose insulin to replicate the steady stream of the hormone that healthy people produce over 24 hours.

It’s “the holy grail of diabetes treatment,” Hendricks said of the once-daily insulin dosing. Diabetics typically have to inject multiple times a day to keep insulin levels steady.

Tresiba sales

Novo’s American depositary receipts jumped 7.3 percent to $159.75 just as the announcement was made before the 4 p.m. close of regular New York trading. The gain was the biggest since Oct. 27, 2011. The company’s shares in Denmark fell 0.7 percent to 865 kroner earlier in the day.

Tresiba’s approval is supposed to produce about 9 billion kroner ($1.5 billion) in 2016 for Novo, according to the average of eight analysts’ estimates compiled by Bloomberg. Tresiba has been approved for sale in Japan and won the backing of a European Union advisory panel on Oct. 19. The FDA has yet to set a deadline for making a final decision on the drug.

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’s Avandia were restricted because of increased heart attack risk

Impractical trial

Novo proposed conducting a trial to assess the cardiovascular risk of Tresiba after approval. The trial would include 7,500 patients and last five years. The panel didn’t vote on whether the trial should be 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.

The panel said it was difficult to determine whether the cardiovascular risk FDA staff found, which they first outlined in a report Nov. 6, was real because Novo didn’t run its trials to test for heart risks. Rather the staff looked at composite results from 17 studies. FDA staff said during the meeting that a trial to assess a safety signal typically is conducted once a drug is on the market.

Sanofi testimony

Novo attempted to prove Tresiba lowered the risk for hypoglycemia, or low blood sugar, over other insulins. The company had said in June that the drug had a benefit over Sanofi’s Lantus in reducing hypoglycemic events.

The injection “did not suggest a clear benefit or harm” over comparators for hypoglycemia in Type 1 diabetes, FDA staff said in a report ahead of the meeting. The data were presented at the advisory panel meeting today. Consistent findings for a benefit in hypoglycemia are lacking between trials, the staff said.

Sanofi’s Lantus lowered blood sugar comparably or more than Tresiba in other published studies, Sanofi’s Riccardo Perfetti, vice president of medical affairs for global diabetes, said in public testimony during the panel meeting.

Competitors typically don’t testify at advisory panel meetings.

Novo used a definition of hypoglycemia that is less specific than the American Diabetes Association’s definition to reach its findings, said Jean-Marc Guettier, clinical team leader in FDA’s Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research.

Diabetes is the seventh-leading cause of death in the U.S. and is the leading cause of kidney failure and nontraumatic lower-limb amputations, the CDC said.

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