An energized FDA has come through with an approval of Novo Nordisk’s once-weekly GLP-1 diabetes drug semaglutide, opening the door to a market many analysts are convinced is worth more than $2 billion a year in peak sales. And it could spell big trouble for rival Eli Lilly.
Type 2 diabetes is a massive and fast-growing disease, with a global market that has rewarded a handful of key players like Novo Nordisk a multibillion-dollar market. And Novo ran a typically thorough Phase III program.
In doing so, Novo also came up with superior data to Eli Lilly’s Trulicity, setting up a head-to-head showdown that could cost Lilly dearly.
Researchers also came up with some troubling instances of diabetic retinopathy, which can lead to blindness. But a near unanimous vote by a group of outside experts at the FDA felt that was an issue that could be monitored, in light of the benefits in glycemic control the drug offered.
Novo also isn’t done with the development of this drug, now Ozempic, for the big US market. Researchers are busily putting it through another big test as an obesity therapy after triggering some impressive weight loss among obese patients. And they would be squaring off against some unimpressive rivals now on the market.
In an R&D update during its Capital Markets Day at its HQ near Copenhagen just days ago, investigators for the company said they will recruit 4,500 patients for a Phase IIIa obesity trial for semaglutide. And they plan to launch the 68-week study next year, alongside a “landmark” cardiovascular outcomes study with 12,500 people enrolled.
“We are very excited about the first approval of Ozempic and look forward to making this important innovation available to people in the US with type 2 diabetes in the beginning of 2018,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer, in a statement. “Type 2 diabetes is a complex disease, but with the unique clinical profile of Ozempic, we believe it has the potential to set a new standard for the treatment of the disease.”
The FDA is now just a few approvals from breaking the 45 NDAs offered in 2015.
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