Novo Nordisk seeks to get US OK for Tresiba in first half of next year

Novo Nordisk A/S is aiming to get the approval from U.S. Food & Drug Administration for its experimental diabetes medicine Tresiba in the first half of next year after getting the backing of the advisory panel to the FDA, says Novo’s Chief Scientific Officer Mads Krogsgaard Thomsen.

The heart risks with the medicine, also known as insulin degludec, probably are not enough of a concern to block its approval, a majority of FDA advisers said. Mr. Thomsen also said, “For sure we will target working with the agency in such a way that we can get the approval in the first half of next year.”

The FDA has not given any date it expects to complete the Tresiba review to Novo Nordisk,  he noted. Novo needs Tresiba to help bridge the gap with France’s Sanofi, whose best-selling Lantus insulin last year generated 3.92 billion euros ($5 billion) in revenues.

Tresiba has been approved for sale in Japan and also won the backing of a European Union advisory panel on October 19.

The company Novo is still conducting a post-approval cardiovascular outcomes study for another of its diabetes treatments, Victoza.  Mr. Mads Krogsgaard also said, “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.

Novo is the world’s largest insulin maker. It provides sufficient efficacy and safety data to support the marketing degludec for use alone or in combination with an insulin to increase the blood-sugar control during meals.

An analyst with Leerink Swann & Co, Mr. Seamus Fernandez said, the FDA probably will delay the approval of Tresiba 6 to 12 months. Novo Nordisk manufactures and markets pharmaceutical products and services. It was formed out of the merger of 2 Danish companies.