Novo's weekly GLP-1 aces two head-to-head trials against Januvia, Bydureon

Novo Nordisk

NEW ORLEANS--Novo Nordisk has staked out a big portion of its pipeline for semaglutide, the once-weekly GLP-1 drug that could follow in the footsteps of its blockbuster daily, Victoza. And this weekend, it rolled out new data pitting the drug head-to-head against two future competitors.

Semaglutide topped AstraZeneca’s weekly GLP-1, Bydureon, and Merck & Co.’s Januvia, a DPP-4 med and fellow incretin mimetic, in two separate studies in Type 2 diabetes.

The two studies, SUSTAIN 2 and SUSTAIN 3, showed “very consistent and excellent improvements in efficacy versus Bydureon or Januvia,” Novo CMO Todd Hobbs told FiercePharma.

“The way I describe it is that the strongest daily GLP-1 is Victoza, and we feel really strongly that semaglutide is the strongest weekly,” Hobbs added, in an interview at the American Diabetes Association meeting here Sunday.

The Novo drug beat Januvia by a bigger margin, with reductions in A1C of 1.3% for a 0.5-mg dose and 1.6% for a 1-mg dose compared with 0.5% with Januvia. Both drugs were tested as add-ons to metformin and/or thiazolidinediones, which are older, standard therapies.

In the head-to-head study against Bydureon, a 1-mg dose of semaglutide helped patients lower their A1C levels by 1.5%, compared with 0.9% for the AstraZeneca drug. The two meds were tested alongside one of three older therapies.

The stats were taken at the 56-week mark. In addition to the A1C margins, semaglutide did better than both meds at helping more patients hit their A1C goal of less than 7%. In the Januvia trial, 69% of the patients on 0.5 mg of semaglutide and 78% of those on the 1-mg dose hit that goal, versus 36% of Januvia patients. Two-thirds of semaglutide patients in the other trial achieved their A1C goal, compared with 40% of the Bydureon patients. And the semaglutide patients lost significantly more weight--up to 6.1 kg, for the 1-mg dose in the Januvia trial.

The studies were part of Novo’s SUSTAIN research program, with 7 trials either completed or in process. The Danish drugmaker plans to submit all that data to the FDA in the fourth quarter, with a potential approval on tap for late 2017.

Semaglutide wouldn’t be the first weekly GLP-1 on the market. AstraZeneca’s Bydureon holds that title, and in 2014, Eli Lilly won FDA approval for its weekly med, Trulicity. So far, the daily Victoza has lost a few percentage points off its market share to the Lilly drug, with 51% as of March. But both companies maintain that ongoing growth in the GLP-1 class will leave plenty of room for Victoza and Trulicity, which now has a 16% share. Bydureon and its daily counterpart, Byetta, together represent 21% of the GLP-1 field, and GlaxoSmithKline’s ($GSK) weekly product, Tanzeum, remains in the single digits.

“Semaglutide would be the fourth weekly to market,” Hobbs noted, “but the data we’ve seen so far against the weekly competitors is really strong, and we will go to payers with that. Also, the cardiovascular outcomes trial data is very unique.”

The SUSTAIN program includes a cardiovascular outcomes trial, required by the FDA for all diabetes drugs since 2008. Semaglutide’s outcomes numbers, from the SUSTAIN 6 trial, are due for release later this year; so far, the company has only said that it delivered a “statistically significant reduction.”

Data from other outcomes studies have made headlines over the past year, after Eli Lilly and Boehringer Ingelheim’s SGLT2 drug Jardiance proved not only to be safe for the heart, but to cut the risk of cardiac death, heart attack and stroke, a first for a diabetes med.

Since the Jardiance outcomes trial made its debut, Victoza also pulled off a CV risk reduction. Full data on the those results, from the LEADER trial, are set for presentation at the American Diabetes Association’s Scientific Sessions on Monday afternoon, in one of the most highly anticipated presentations of the meeting.

Novo is also testing an oral version of semaglutide, which would be taken daily. After encouraging Phase II results last year, the drugmaker advanced the oral formulation into Phase III with its PIONEER program. Eight studies are planned as part of that program, with the first set to read out next year. A daily injectable is also in development for Type 2 diabetes and weight loss.

- see the Novo release on SUSTAIN 6

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