Novo Nordisk A/S (NOVOB) is aiming for U.S. approval of its experimental diabetes medicine Tresiba in the first half next year, after obtaining the backing of an advisory panel to the U.S. Food and Drug Administration, Mads Krogsgaard Thomsen, Novo’s chief scientific officer, said.
Heart risks with the medicine, also known as insulin degludec, are probably not of enough concern to block its approval, the majority of an advisory panel to the FDA said yesterday.
“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, Demmark. The FDA has not yet informed Novo of a date by when it expects to complete its review of the medicine, Thomsen 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 today. 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. The FDA isn’t required to follow the panel’s advice.
“It was a vivid, constructive debate,” Thomsen said. “This is how the FDA advisory committee works. They are mandated to stress-test” the benefits and risks of new products, he added. Tresiba’s potential won’t “by any means be impacted” negatively by today’s panel discussion, Thomsen said.
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