FDA

FDA experts shrug off retinopathy concerns, offer (near) unanimous thumbs up for Novo Nordisk’s semaglutide

An FDA panel of outside experts today voted almost unanimously to endorse Novo Nordisk’s next big diabetes/obesity drug semaglutide, likely setting up a near-term approval for one of this year’s top blockbusters in the pipeline. There was one abstention and zero opposition to the key question.

Novo Nordisk is a major player in diabetes and predictably ran a thorough late-stage effort to nail down their drug’s ability to lower HbA1c — a critical measure for the control of the disease. In the process, though, they also carefully tracked incidents of diabetic retinopathy — damage to the blood vessels in the eye, which can lead to blindness — spotlighting what would become a big issue for its scientists on Wednesday.

According to Novo Nordisk, no one else has done similar eye exams as researchers decided to do in their big SUSTAIN 6 outcomes study. In their case, the scientists maintained that the drug wasn’t directly responsible for incidents of retinopathy, but rather pinned the blame for the cases on the sudden drop in HbA1c which the drug was responsible for. And that risk could be managed, the company says, through the right warning label to alert patients who are at risk.

The FDA, while offering a clear nod for the drug’s efficacy profile, made these retinopathy cases the central feature of the panel discussion, asking the experts to either sign off on the adverse safety issue as something that could be managed or stop the drug now until more data could be gathered.

Eli Lilly has a lot riding on the final outcome for Novo Nordisk. In its last big Phase III trial, SUSTAIN 7, researchers pitted semaglutide against Lilly’s up-and-coming GLP-1 drug Trulicity, and beat it. An aggressive marketer, Novo will go toe-to-toe with Lilly in the global diabetes market if it gets the chance.

Novo is also developing semaglutide specifically for obesity, a market that has defied several recent attempts by small biotechs with only relatively modest amounts of weight loss to boast about. And there is also a program underway in NASH.

Pegged as a potential $2.2 billion drug in 5 years in one recent assessment, Novo execs during their Q2 call reviewed the Phase II obesity data they had nailed down in June, outlining plans for a looming Phase III that they believe can show their GLP-1 drug can knock off up to around 15% of an obese person’s weight relative to placebo.

If semaglutide gets a clean bill of health from regulators, as appears likely, Novo can start testing those forecasts.

It’s also worth noting that an approval here would shove up the FDA’s record for 2017 to 35 or more, putting it on track to return to the strong approval rate for new drugs regulators scored in 2015, before seeing a big dropoff in 2016. The FDA has already registered a record number of OKs on the generics front, as new commissioner Scott Gottlieb follows through on his list of goals at the FDA.


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