FDA accepts Novo Nordisk’s resubmitted Application for Tresiba
Danish multinational pharmaceutical company Novo Nordisk announced that the US Food and Drug Administration (FDA) has accepted its application for the company's key insulin drug, Tresiba, based on interim analysis data from a clinical trial. According to reports, the application was resubmitted by the pharmaceutical company headquartered in Bagsvaerd, Denmark.
Novo Nordisk's Tresiba was refused by the federal agency of the United States Department of Health and Human Services about two years ago. According to the agency, there are chances that the drug could be associated to higher rate of heart attack or stroke. Novo Nordisk's drug is available outside the United States.
FDA asked the company to have a dedicated trial to test for risks like heart attacks. Novo announced on Tuesday that the study could be completed in the second half of 2016. Last month, Novo said that it was looking to resubmit its application for Tresiba drug.
According to industry analysts, Novo's Tresiba could get approval as early as October 2015, based on interim data. As the company said that the trial of the drug will be completed in the second half of 2016, so there are chances that Tresiba would not likely to hit the United States market in 2016.
Tresiba is a long-acting form of insulin known chemically as degludec. As per the Thomson Reuters Cortellis, Tresiba is presently forecast to generate annual sales of $2.2 billion by 2020. In a research note in March, Morningstar's Karen Andersen said, "Tresiba gives Novo an important foundation for future combination regimens in the United States, which accounts for slightly more than half of a $23 billion global diabetes market".
While talking to Reuters in March last year, Novo Chairman Göran Ando said that getting Tresiba approved by the United States FDA was one of the most important short-term goals of the company.