Novo Nordisk and Eli Lilly are locked in a tough fight, both vying for the top spot in the GLP-1 diabetes treatment class. On strategy they’ve both pursued is increasing the dosing of their existing offerings to reach better efficacy. Now, Novo has made its regulatory move.
Wednesday, the Danish company said it had filed for U.S. approval of once-weekly Ozempic at a new dose of 2.0 mg. The GLP-1 analogue currently comes at two lower doses of 0.5 mg and 1.0 mg. It submitted the same label extension request to EU regulators in late December.
The news came after Lilly in September secured a U.S. nod for rival once-weekly GLP-1 drug Trulicity to include 3.0 mg and 4.5 mg doses on top of the original 1.5 mg offering.
Both drugs have shown they work better in diabetes patients when given at higher doses. For Ozempic specifically, in the phase 3b Sustain Forte trial, the 2.0-mg dose showed a statistically significant reduction in blood sugar levels compared with the 1.0-mg dose at week 40. More patients on the high dose achieved the American Diabetes Association treatment target of HbA1c—a commonly used metric for blood sugar—below 7%. The high-dose takers also lost more bodyweight than their low-dose counterparts did.
Ozempic’s been growing aggressively since its launch in 2018 as Lilly’s earlier-to-market Trulicity plays defense, even though the entire GLP-1 share in the diabetes market continues to increase thanks to the two drugs.
As of 2020’s third quarter, the two drugs were neck and neck in terms of U.S. new-to-brand share, with Ozempic at 34.7% and Trulicity 34.5%. Total scripts share was 44.3% for Trulicity, versus 26.8% for Ozempic.
But the focus at Novo Nordisk these days also includes newly launched Rybelsus, an oral drug that shares injectable Ozempic’s active ingredient, semaglutide. Approved by the FDA in September 2019, the drug is viewed as a market disrupter.
Merely 20 weeks into its launch, Rybelsus enjoyed new-to-brand share that matched that of the entire SGLT2 class, which also consists of oral medications. While its share slipped during the first few months of the COVID-19 pandemic, it has returned and been ticking upward as lockdowns lift. More good news for Novo: Over 80% of the drug's new scripts went to patients new to the GLP-1 class, CEO Lars Fruergaard Jørgensen said during a call in October.
During the third quarter of 2020, Novo also launched a phase 1 trial testing higher doses of oral semaglutide for diabetes.
Combined, Novo’s GLP-1 franchise, which also includes old stalwart Victoza, generated sales of DKK30.05 billion ($4.9 billion) during the first nine months of 2020, with Ozempic contributing half of that. By contrast, Lilly’s Trulicity hauled in sales of $2.9 billion during the same period after 22% year-over-year growth.
Novo’s ambitions for semaglutide lie beyond diabetes. Last month, the company filed a 2.4 mg, once-weekly version of the under-the-skin drug to the FDA as an obesity treatment after showing weight loss of around 15% to 18% across three phase 3 trials.
The drug also recently showed promise in non-alcoholic steatohepatitis (NASH) in a phase 2 trial, though industry watchers mostly expect it to be able to help earlier-stages patients but not those with heavier liver fibrosis. In a more surprising move, Novo unveiled in mid-December that it would launch a phase 3 trial of oral semaglutide in Alzheimer’s disease.
Lilly has its countermeasure taking shape, too. Its GIP and GLP-1 dual agonist tirzepatide just nailed a phase 3 trial in diabetes, showing significant improvements in blood sugar levels and body weight that were superior to placebo’s data. But both Lilly and Novo, as well as industry watchers, will be more interested in the readout from a second phase 3 trial dubbed Surpass-2, which pits tirzepatide against Ozempic.