2nd time’s the charm? Novo Nordisk reups bid for high-dose Ozempic after March FDA snub

By | May 31, 2021

Novo Nordisk is back for round two with a new Ozempic dosing regimen. The diabetes specialist resubmitted to the FDA on Friday after a March snub, renewing its bid to compete with Eli Lilly’s already approved higher dose.

Novo’s resubmission aims to nab an approval for a once-weekly, 2-mg dose for Ozempic, a GLP-1 drug already approved for weekly dosing at 0.5 mg and 1 mg. The latest attempt follows an FDA refusal to file letter suggesting serious shortfalls in the company’s application. 

The FDA specifically asked for more information about a potential new production site in Denmark, a Novo spokesperson told Fierce Pharma in March. The spokesperson said they didn’t believe Novo would need to file any additional clinical data to score its Ozempic label extension.

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Novo first applied for the 2-mg Ozempic dose back in January, shortly after Lilly’s Trulicity added 3-mg and 4.5-mg doses to its U.S. label. 

Despite both companies’ bids for higher doses, the lower-dose versions of Ozempic and Trulicity will likely be the “workhorse” versions of the drugs, Bernstein analyst Ronny Gal predicted in February. While the stronger versions boast greater efficacy, the side effect burden is higher, and patients’ failure to stick to therapies is already a major issue in diabetes treatment, he said. 

The other drug likely on Novo’s mind is Lilly’s tirzepatide, a dual GIP/GLP-1 agonist that recently trumped Ozempic in a head-to-head trial. At all three doses tested in the late-stage trial, tirzepatide beat Ozempic in reducing blood sugar levels and body weight. 

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Bernstein’s Gal is placing his bets on the lower doses of the drugs—5 mg for tirzepatide and 1 mg for Ozempic—as the versions likely to see the most use in the real world. The trial didn’t compare tirzepatide to the 2-mg Ozempic dose Novo is now angling to get approved. 

Ozempic last year pulled in 21.21 billion Danish kroner ($ 3.42 billion) in sales, eclipsed by Trulicity’s $ 5.07 billion. Still, Novo is hoping its newly minted oral semaglutide option Rybelsus can help pick up the slack. As of January, that drug had gobbled up 4.7% U.S. total GLP-1 script share and 11.5% new-to-brand share.

Rybelsus also seems to be popular among patients who’ve never tried a GLP-1. Novo noted that group comprised more than 80% of its new scripts.

And Novo’s got another GLP-1 ace up its sleeve. It’s applied for semaglutide as a treatment for obesity with a 2.4-mg under-the-skin dosing regimen. Ahead of that expected green light sometime in the second quarter, Novo has entered “full go mode” for its obesity launch, Doug Langa, executive vice president for North America, told Fierce Pharma in early May.

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