Novo Nordisk notches another phase 3 success for GLP-1 drug
- Novo Nordisk's next-gen GLP-1 drug semaglutide met its headline objective in its fifth successful phase 3 trial, a string of successes which position the weekly diabetes treatment as an heir to its existing Victoza.
- Among 397 participants with type 2 diabetes, trial results showed a statistically significant reduction in glycemic levels from both the 0.5 mg and 1.0 mg dosing levels, compared to a placebo. Just under four-fifths of patients treated with 1.0 mg achieved target blood glucose levels of 7%—the target established by the American Diabetes Association.
- Novo plans to announce results from the sixth and final trial in the first half of 2016.
As the global incidence of diabetes continues to increase, the market demand for better therapeutics and new product entrants remains unabated. In 2014, the top 10 diabetes drug manufacturers generated $62 billion in revenues, according to GlobalData. That same year, the diabetes therapeutics market grew by a further 5.1%.
Given the opportunities, the competition in this market is fierce. Right now, the top two companies in the diabetes space—Novo and Sanofi—are competing to see which company will bring the next blockbuster diabetes med to market. Both have looked to analogs of the hormone GLP-1, which increases the natural production of insulin.
Yesterday, Sanofi reported that it is using a priority review voucher to expedite the review process for its investigational GLP-1 drug, LixiLan, by four months. LixiLan combines Sanofi's long-lasting insulin Lantus with the GLP-1 compound lixisenatide.
Sanofi is facing new challenges in the diabetes space as its Lantus patent recently expired in key markets. And at the beginning of 2016, the French company terminated its development project with the troubled Mannkind for the inhaled insulin product Afrezza.
For its part, Novo is moving into the sixth phase 3 trial for the semaglutide program, even as the company puts off submission of Xultophy, an investigational product combining the long-lasting insulin Tresiba with Victoza, until next fall.