Novo Nordisk had some more upbeat pipeline news to report Wednesday afternoon, as researchers rolled out new Phase III data showing their GLP-1 drug semaglutide — a would-be blockbuster — beat out Eli Lilly’s Trulicity (dulaglutide) in a head-to-head showdown.
Of particular note: Novo’s drug sailed through SUSTAIN 7 with comparable instances of diabetic retinopathy with the comparator drug from Lilly. That may help qualm fears raised by earlier study results.
“(F)or me, the #1 focus going into this press release was whether Novo’s drug may have an imbalance on retinopathies (based on findings from prior trial) … and it didn’t (best case for Novo),” concluded Evercore ISI’s Umer Raffat.
Investigators tested two doses of semaglutide and Trulicity; 0.5 and 1.0 mgs compared to 0.75 and 1.50 mgs. Working off a mean baseline for A1C of 8.2%, the two doses of semaglutide sliced that figure by 1.5% and 1.8% compared to 1.1% and 1.4% for Trulicity. That led to significantly higher rates of semaglutide patients hitting their treatment goals than the rival drug.
Even better, the differences in weight gain were dramatic for semaglutide, which is heading into a Phase III obesity program with high hopes for the market to come. Average weight loss for the two doses were least twice as high with semaglutide than Trulicity, which will give this drug a clear benefit for large numbers of overweight diabetics. At the higher dose the average weight loss with 6.5 kilos compared to 3.0 kilos.
Novo has this drug under review at the FDA and EMA after a full slate of clinical studies.
Lilly execs won’t like the competition, if it wins approval. The drug was its top-performing new drug in 2016, earning $337 million. Novo, meanwhile, has proven to be a tough competitor in the massive diabetes market, but has also been feeling the pain of pricing pressure that has afflicted all the big players, including Sanofi.
“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” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We are excited about the potential of semaglutide to set a new standard for treatment of type 2 diabetes.”
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