Two new diabetes treatments, Tresiba (insulin degludec injection) and Ryzodeg (insulin degludec/insulin aspart injection), have been approved by the U.S. Food and Drug Administration.
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Both treatments are made by Novo Nordisk, based in Plainsboro, N.J.
FDA also approved the company’s Ryzodeg, an injection that combines Tresiba and a fast-acting form of insulin. “The USA market for basal insulin represents over 80 percent of the global market”, said Soren Lontoft Hansen, senior analyst at brokerage firm Sydbank.
“The labeling did come out largely as we had anticipated”. The FDA had declined to approve Tresiba in 2013, asking for more data on risks of heart problems from using the drug. Novo Nordisk shares are heading in the right direction of their best day in six months.
Tresiba (insulin degludec) is a once-daily new-generation basal insulin analogue with a half-life of 25 hours and a duration of action of at least 42 hours. The world’s largest insulin maker expects to launch Tresiba in the United States during the first quarter of 2016.
As an ultra-long acting product, Tresiba is sold at a premium to other insulins.
Novo Nordisk will be breathing a huge sigh of relief after U.S. regulators finally opened the door to its re-filed diabetes drugs Tresiba and Ryzodeg. The trial is still expected to have accrued the prespecified number of major adverse cardiovascular events (MACE) for the full trial analysis in mid-2016.
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The FDA’s approval came after two years of the drug’s rejection. Novo Nordisk management does not have access to the results of the interim analysis.
