The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the American Food and Drug Administration (FDA) has voted in favour of approving Novo Nordisk’s new product Saxenda, a drug for the treatment of obesity, the company announced in a press release yesterday.
The panel voted in favour of the drug by a convincing 14 to 1, an important step in the process of getting the drug approved for sale in the lucrative American market.
“We are pleased with the clear recommendation from the advisory committee,” Mads Krogsgaard Thomsen, the company’s chief science officer, said in the press release.
“We look forward to working with the FDA as they complete their review of Saxenda. Obesity is a serious public health issue in the US and we are committed to making Saxenda a new treatment option for adults with obesity.”
Børsen reports that the news was also greeted favourably by the company’s shareholders, including the pension company PFA, which reportedly has 4.5 billion kroner at stake.
Jesper Langmack, the head of PFA, told Børsen that the share price has risen in expectation of FDA approval. “It will rise even more this morning,” he said. “So we’re of course very happy about the news, even though a no wouldn’t have changed our long-term view of Novo – just reduced potential in the share price.”
The new drug application (NDA) for Saxenda was submitted by Novo Nordisk to the FDA on 20 December 2013.