Novo Nordisk and Eli Lilly are embroiled in an uphill battle, both fighting for the top spot in the GLP-1 diabetes treatment class. The strategy they both have followed is to increase the dosage of their existing offerings for better effectiveness. Now Novo has taken its regulatory steps.
The Danish company announced on Wednesday that it had applied for US approval of Ozempic once a week in a new dose of 2.0 mg. The GLP-1 analog is currently available in two lower doses of 0.5 mg and 1.0 mg. At the end of December, she submitted the same application to EU regulators to renew the label.
The news came after Lilly received a US nod in September for the once-weekly competing GLP-1 drug Trulicity, which added doses of 3.0 mg and 4.5 mg in addition to the original 1.5 mg offering.
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Both drugs have been shown to work better in diabetic patients when given in higher doses. Specifically for Ozempic, the 2.0 mg dose in the Phase 3b Sustain-Forte study showed a statistically significant decrease in blood glucose levels compared to the 1.0 mg dose at week 40. More patients achieved the high dose the American Diabetes Association’s treatment goal of HbA1c – a commonly used metric for blood sugar – below 7%. The high-dose consumers also lost more body weight than their low-dose counterparts.
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Ozempic has grown aggressively since its launch in 2018 as Lilly’s earlier-launched Trulicity is a defense, even though the overall GLP-1 share of the diabetes market continues to grow thanks to the two drugs.
As of Q3 2020, the two drugs were tied for the U.S. fresh start percentage in the U.S., with Ozempic at 34.7% and Trulicity at 34.5%. The total amount of scripts was 44.3% for Trulicity versus 26.8% for Ozempic.
However, the focus at Novo Nordisk these days is also on the newly launched Rybelsus, an oral drug that contains Ozempic’s injectable ingredient, semaglutide. The drug was approved by the FDA in September 2019 and is considered a market disruptor.
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Just 20 weeks after its launch, Rybelsus had a new brand share equal to that of the entire SGLT2 class, which also consists of oral drugs. While its share slipped in the first few months of the COVID-19 pandemic, it returned and ticked up as lockdowns increased. 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.
In the third quarter of 2020, Novo also started a phase 1 study testing higher doses of oral semaglutide for diabetes.
Together, Novo’s GLP-1 franchise, which includes the old, unwavering Victoza, had sales of DKK 30.05 billion ($ 4.9 billion) in the first nine months of 2020, with Ozempic being the Contributed half of it. In contrast, Lillys Trulicity had sales of $ 2.9 billion over the same period, up 22% year over year.
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Novo’s ambitions for semaglutide are beyond diabetes. Last month, the company filed with the FDA a once-weekly version of the drug under the skin at 2.4 mg as a treatment for obesity, after seeing weight loss of around 15% to 18% in three Phase 3 studies.
The drug has shown promise in a recent Phase 2 study in non-alcoholic steatohepatitis (NASH) as well, although industry observers mostly expect it to be able to help early-stage patients but not patients with severe liver fibrosis. In a more surprising move, Novo announced in mid-December that it would start a phase 3 study of oral semaglutide in Alzheimer’s disease.
Lilly’s countermeasure is also taking shape. Its GIP and GLP-1 double agonist, tirzepatide, has just completed a phase 3 study in diabetes and showed significant improvements in blood sugar levels and body weight that were superior to the placebo data. But both Lilly and Novo and industry watchers will be more interested in viewing a second Phase 3 trial, called Surpass-2, using Tirzepatide against Ozempic.
