- The Food and Drug Administration will not start reviewing a new, higher dose of Novo Nordisk's diabetes medicine semaglutide, the Danish drugmaker announced Tuesday, indicating the agency asked for more manufacturing data in what's known as a "refuse-to-file" letter.
- Semaglutide is already approved to treat Type 2 diabetes in the U.S. The injectable version of the drug, sold by Novo as Ozempic, is given once weekly at either 0.5 mg or 1.0 mg doses. A trial run by Novo, however, found a 2.0 mg dose better controlled blood sugar levels, so the drugmaker aims to expand the drug's label to include a higher dose. Novo also sells an oral formulation as Rybelsus.
- Refuse-to-file letters from the FDA aren't uncommon, but they're notable setbacks, especially for larger and more experienced companies like Novo. The drugmaker expects to refile its application by June, and noted that it believes it has all the clinical trial data it needs already.
The FDA's letter to Novo is the latest example in a series of regulatory pushbacks that some analysts view as signs of tougher oversight from the agency.
In recent weeks, the FDA has surprised Acadia Pharmaceuticals with an unexpected notice of "deficiencies" in the company's drug application and FibroGen with the unexpected scheduling of an advisory committee meeting. Reviews of drugs from AbbVie and Kadmon, meanwhile, have been extended past scheduled decision dates.
More broadly, the agency is in the midst of an "industry-wide" review of accelerated approvals for cancer immunotherapies, and appears to be enforcing a tough line on manufacturing with cell and gene therapy developers.
"We believe the industry and its investors will need to adjust to a different regulatory environment to the one they have enjoyed for the last 5 years," wrote Geoffrey Porges, an analyst at SVB Leerink, in a March 23 note to clients.
Porges cited several factors in his assessment, including "more challenging drug reviews" at the FDA.
Novo's setback with semaglutide comes as a surprise as well, according to Cowen's Steve Scala, although the analyst noted he's "inclined to take this news at face value." In its statement, Novo said the FDA's concerns were specific to a proposed new manufacturing site, rather than reflective of a broader clinical concern.
If approved, the 2.0 mg dose could help Novo compete against an experimental drug from rival Eli Lilly that's moving through late-stage testing. Studies recently showed the drug, called tirzepatide, outperformed semaglutide on measures of both blood sugar control and weight loss.
Novo is also hoping to win approval of semaglutide as a treatment for obesity. The drugmaker completed an application to the FDA in December and requested a priority review.
Shares in Novo listed on the New York Stock Exchange lost about 3% of their value in Tuesday morning trading.