Novo Nordisk ($NVO) and its profit-growth plans hit a roadblock earlier this year when the FDA refused to approve its new diabetes drug, Tresiba, without a new safety study. But CEO Lars Sorensen thinks he has an alternate route through a new weight-loss indication for the already top-selling Victoza.
That drug has already racked up some positive weight-loss data. One study, pitting Victoza against Merck's Januvia, found that Novo's drug helped diabetics lose more weight than Merck's ($MRK) did. The FDA was impressed enough to allow Novo to add that data to Victoza's label. More recently, Novo touted a weight-loss-specific trial, which showed that patients using a 3-mg dose of Victoza lost 6% of their body weight, compared with 2% of placebo patients.
Those results compare favorably with the new generation of obesity fighters--the Vivus ($VVUS) drug Qsymia, launched last year, and Arena Pharmaceuticals' ($ARNA) Belviq, now preparing for a rollout next month. First-quarter Qsymia sales, reported by Vivus this morning, continued their weak trend. Expectations for Belviq aren't huge either, given the reimbursement difficulties around weight-loss meds.
Market research firm Decision Resources, in fact, recently pegged Victoza as the market share leader in obesity if Novo is able to win approval for a weight-loss indication. Doctors are already familiar with the drug because of its use in diabetes, the firm said. And a survey of endocrinologists found that 20% expect to give Victoza to their overweight and obese patients.
Meanwhile, there's Tresiba. As Reuters reports, Sorensen acknowledges that the U.S. market is key to Tresiba's success. So regardless of approvals in Europe and Japan, Novo really needs that FDA nod. "The U.S. represents something like 50% of our growth potential," he said at the Reuters Health Summit.
That new Tresiba cardiovascular-safety study will require years of data collection. Best-case scenario, Tresiba could get onto the U.S. market in three years, Reuters says, provided the FDA is willing to review it again based on interim study data.