Novo Nordisk ($NVO) declared victory after an FDA advisory committee meeting on the company's long-lasting insulin product degludec or Tresiba, a blockbuster hopeful, and some investors appeared to agree as Novo's stock climbed more than 10%. Citing a company official, Bloomberg reported that Novo is angling for U.S. approval in the first half of 2013.
The agency panel backed approval of the basal insulin analog and another therapy that combines it with a bolus insulin boost in a mixed 8-4 vote on Thursday. And after FDA staff identified a heart risk signal in an earlier analysis of degludec data, the panel voted unanimously in favor of Novo conducting a cardiovascular outcomes study. The FDA will weigh the advice of the non-agency experts in its decision, a date for which hasn't been set. The panel didn't say whether the outcomes study should take place before or after FDA green-lights degludec, and analysts speculated on how concerns about heart risks could impact the timing of hoped-for approvals and commercial success in the key U.S. market.
Bagsvaerd, Denmark-based Novo is the world's largest insulin maker but it needs Tresiba to fill a hole in its lineup of diabetes therapies--a long-acting insulin product that can go toe-to-toe in the market with Sanofi's ($SNY) $5 billion seller Lantus. Diabetes afflicts more than 25 million Americans, and long-lasting insulin is among the measures that can be used to control blood sugar levels. Tresiba, which has been approved only in Japan, offers a once-daily dose of basal insulin and lower risk of hypoglycemia, a condition when blood sugar gets so low that it's a health hazard.
Yet cardio risks have been a major concern for diabetes therapies, punctuated with the heart problems associated with GlaxoSmithKline's ($GSK) infamous Avandia, which has been pulled from the market in Europe and given to U.S. patients on a limited basis because of restricted use. For Novo, it seems all but certain that the FDA will require the cardiovascular outcomes study to answer lingering questions about heart risks. As Reuters reported, Novo placed the cost of the cardio study at a sizable $256 million.
Novo filed for U.S. approval of degludec last year with the goal of gaining the FDA's nod to sell the drug this year, but those hopes were dashed with the agency's delays with its review. Given the agency's track record on diabetes drugs, Leerink Swann analyst Seamus Fernandez wagered in a note Thursday night that Novo faces a 6-12 month delay on the FDA's decision and a label that notes heart risks.
Bernstein analyst Tim Anderson gave his own sobering assessment of the panel votes, saying in a note, as quoted by Bloomberg: "Even with a positive recommendation, the commercial outlook for degludec is probably meaningfully impaired."
Editor's Note: Added Novo's projected cost of the FDA panel's endorsed cardiovacular outcomes study from Reuters.