Dive Brief:
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Novo Nordisk's Ozempic met its primary endpoint in a Phase 3b study of 302 Type 2 diabetes patients already on treatment with an SGLT-2 inhibitor, beating out placebo in lowering blood sugar, according to newly released data published in The Lancet.
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The injectable GLP-1 receptor agonist also achieved the study's secondary goal, helping patients in the treatment arm lose more weight over 30 weeks than those on placebo.
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The study is the company's ninth in a global, 10-trial program that enrolled more than 8,700 long-time Type 2 diabetes patients. Continued clinical success is crucial for Novo, which faces a competitive diabetes market and a GLP-1 rival in Eli Lilly's Trulicity.
Dive Insight:
Though Novo's market share for Ozempic (semaglutide) has grown, Eli Lilly's Trulicity (dulaglutide) remains a strong competitor. At the end of January, Ozempic held a 24% share of weekly new-to-brand prescriptions in the GLP-1 market, below Trulicity's 36%, according to Iqvia sales estimates cited by Credit Suisse.
Credit Suisse analyst Vamil Divan wrote in a February note that Novo's fiscal 2018 results "highlighted continued progress for their GLP franchise," which saw a 19% bump in sales driven by Ozempic.
Aiming to further build Ozempic's presence, Novo last year launched a DTC ad campaign for the drug.
Amid this competitive market, the results Novo released Monday from SUSTAIN 9 could help.
The trial was meant to assess the safety and efficacy of Ozempic, a once-weekly injection, in combination with SGLT-2 inhibitors.
Results showed treatment with Ozempic led to a 1.5% decrease in A1C levels, compared to 0.1% with placebo, a statistically significant difference. Patients randomized to receive Ozempic also lost just under 11 pounds on average, compared to those who received placebo, who lost about 2 pounds.
"Despite current treatment, almost 50% of people with Type 2 diabetes are still living with uncontrolled blood sugar," said Mads Krogsgaard Thomsen, science officer of Novo Nordisk, in a company statement.
Ozempic was approved by the FDA in December 2017. Novo is also developing semaglutide in an oral formulation, which would be the first pill in the GLP-1 class. The company is expected to seek FDA approval for that version sometime this year.