- Novo Nordisk A/S beat out Eli Lilly & Co. in a clinical trial that pitted two of the drugmakers' diabetes medications against each other, though it's unclear how those results may affect market dynamics.
- The late-stage SUSTAIN 7 trial tested two doses of both Novo's semaglutide and Lilly's Trulicity in patients with type 2 diabetes who were also receiving metformin.
- Patients who received the lower doses of those treatments — 0.5 mg of semaglutide versus 0.75 mg of Trulicity once a week — had mean reductions from baseline in glycosylated hemoglobin (HbA1c) of 1.5% and 1.1%, respectively. Those receiving higher doses — 1.0 mg of semaglutide versus 1.5 mg of Trulicity once a week — saw their HbA1c levels fall 1.8% and 1.4% from baseline, respectively.
Novo's drug may have significantly bested Lilly's, but some investors are wary of exactly how much market share it could snag should it gain approval.
Semaglutide is what's known as a glucagon-like peptide-1 (GLP-1) analog, aiding diabetes patients by promoting insulin secretion and lowering glucagon levels. Other GLP-1s, namely Novo's Victoza (liraglutide), GlaxoSmithKline plc's Tanzeum (albiglutide) and Lilly's Trulicity (dulaglutide), are already approved in the U.S.
The class has proved quite profitable. Trulicity, for example, raked in $480 million during the second quarter, up nearly 140% from the same period in 2016.
To be fair, Trulicity's success is largely due to its fast uptake. Cowen & Co. analyst Steve Scala highlighted in an Aug. 17 investor note that before Trulicity launched, Victoza held a nearly 70% share of new prescriptions on the GLP-1 market. Now, that share has dropped below 50%, while Trulicity has secured about one-third of the market.
Data from a study dubbed AWARD 6 surely helped that uptake, as it showed once-weekly doses of 1.5 mg Trulicity were non-inferior to once-daily 1.8 mg doses of Victoza at significantly reducing HbA1c levels. Many physicians look more kindly on prescribing drugs with easier and less frequent regimens.
Still, with so many strong contenders on the market, it's hard to say how well semaglutide can elbow its way in.
"Semaglutide is an important competitive challenge for [Eli Lilly]," Scala wrote. "However, comparison to [Eli Lilly's] AWARD 6 (Trulicity vs Novo’s Victoza) suggests leading agents in the class should thrive, keyed to prescriber/patient experience/loyalty and underlying class growth."
Additional results from SUSTAIN 7 found 69% of participants on 0.5 mg semaglutide had HbA1c at or below 7% versus 52% of those on 0.75 mg Trulicity after 40 weeks. Among the higher doses, 79% of participants on 1.0 mg semaglutide had HbA1c at or below 7% compared to 68% for those on 1.5 mg Trulicity.
Patients in the study weighed 95 kg with a body mass index (BMI) of 33.5 kg per square meter on average at baseline. Treatment with 0.5 mg semaglutide correlated with significantly greater weight loss — 4.6 kg compared to 2.3 kg for patients on 0.75 mg Trulicity. Patients on 1.0 mg semaglutide also experienced significantly greater weight loss of 6.5 kg to the 3.0 kg with 1.5 mg Trulicity.
Increasingly, diabetes drugmakers have tried demonstrating their medicines are beneficial to cardiovascular health as well as blood sugar. Showing a weight loss benefit in the clinic helps semaglutide's case in that regard.
Novo submitted a New Drug Application for the subcutaneous version of semaglutide in December, while a Phase 3 study evaluating an oral formulation is ongoing and slated to complete next summer. That oral formulation could prove to be the edge Novo needs to break in, offering more convenience and ease of use.
"The superior glucose control and weight loss achieved with semaglutide compared to dulaglutide in this trial reinforces the unprecedented results observed in the entire SUSTAIN programme," Mads Krogsgaard Thomsen, Novo Nordisk's chief scientific officer, said in an Aug. 17 statement.