Higher dose of Victoza helped patients drop weight
While Novo Nordisk already holds 27% of type-2-diabetes market share, data released over the weekend may help the company to further corner this market while providing a buffer against competition.
The drugmaker presented data showing that blockbuster diabetes drug liraglutide (Victoza) may not just stave off diabetes—it may help keep off the pounds, too.
At the American Diabetes Association meeting in San Francisco, the drugmaker said its Phase-III SCALE trial showed that patients taking a once-daily injection of 3mg of liraglutide achieved average weight loss of 5.9% body weight, compared to 2.0% weight loss among those on placebo. Patients who took a lower Victoza dose of 1.8mg reached average weight loss of 4.6% of body weight. All enrolled patients were also put on a diet and exercise program.
Nearly half (49.9%) of subjects achieved “clinically meaningful weight loss of at least 5% when treated with 3mg liraglutide, compared to 35% with 1.8mg,” the company stated.
The FDA had requested that Novo Nordisk study the weight-loss effects of the 1.8mg dose in the SCALE study as a way to evaluate its safety and efficacy in obese adults with and without type 2 diabetes. The drug, as it's currently approved, is only available in a 1.8mg dose for those with this form of diabetes.
Victoza saw $2.1 billion in US sales for 2013, a 31% increase from the year prior, according to IMS Health.
Novo Nordisk submitted new drug applications to the FDA and EMA to support approval of liraglutide 3mg as a weight-loss treatment in December 2013.
The most cited side effects at the new dose, Novo Nordisk said, were gastrointestinal disorders, largely consisting of nausea and diarrhea, and these occurred in 65% of those taking 3mg, 56% of those taking 1.8mg, and 39% of those on placebo.The data may also help cement the competitive position of Victoza relative to Eli Lilly's experimental GLP-1 drug dulaglutide. Lilly's AWARD-6 trial showed dulaglutide has a slightly lower weight-loss profile relative to Victoza, although it promises the convenience of once-weekly administration vs. Victoza, which is used once daily. Lilly is expected to launch dulaglutide later this year.