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The world of obesity therapeutics is witnessing intense competition between two promising drugs - Mounjaro, developed by Lilly, and Wegovy, by Novo Nordisk. As both pharmaceutical giants strive to prove the efficacy of their respective drugs, the race is on to establish the superiority of their treatments in tackling the global obesity epidemic.
The shortages of Eli Lilly & Co.'s Mounjaro have now expanded to encompass all of the higher doses, underscoring the remarkable demand for the drug even before it obtains formal approval for use in obesity. Previously, US regulators reported that three of the higher doses faced "intermittent backorders" through July due to surging demand. The most recent update reveals that a fourth dose has been affected, and issues with another higher-dose option are projected to persist until September, as stated on the Food and Drug Administration website. Presently, only the two lowest doses of the drug are readily available, highlighting the significant interest and anticipation surrounding Mounjaro's potential approval and its potential impact on obesity treatment.
The latest data from the Surmount-3 and -4 trials reveal Mounjaro's impressive performance once again. In Surmount-3, patients underwent a rigorous 12-week program involving intensive caloric restriction, exercise, and counseling. After achieving at least 5% body weight reduction, participants were randomly assigned to either a placebo or Mounjaro, given at a maximum tolerated dose of 10 or 15mg, for 72 weeks. The results were astounding, with participants achieving a remarkable 6.9% mean weight loss during the lifestyle management period. The efficacy estimand, a co-primary endpoint, demonstrated that those taking Mounjaro experienced an average weight loss of 21.1% in the following 72 weeks, while placebo recipients saw a weight regain of 3.3%. Furthermore, an impressive 94.4% of Mounjaro recipients achieved a weight loss of at least 5%, compared to only 10.7% in the placebo group.
In comparison, Novo Nordisk's Step-3 study showed lower mean weight loss but the study design differed significantly, making a direct comparison less fair. Step-3 participants underwent lifestyle management concurrently with drug therapy, taking Wegovy for 68 weeks and attending 30 counseling visits throughout the period.
The pivotal Surmount-4 trial holds even greater significance from a commercial perspective. The Mounjaro lead-in period, which lasted 36 weeks and was open-label, resulted in a remarkable 21.1% mean weight loss for the participants. After that, participants were randomly assigned to take Lilly's Mounjaro for the following 52 weeks or switch to a placebo. During this maintenance phase, the Mounjaro group demonstrated an additional 6.7% weight loss, while placebo patients experienced weight regain of 14.8%.
Novo Nordisk's comparable Step-4 trial involved patients taking Wegovy for 20 weeks before being randomized to either continue or switch to placebo. After an additional 48 weeks, those on Wegovy lost 7.9% of their weight, while the placebo group experienced a regain of 6.9%. With a longer lead-in and maintenance phase, Lilly's Surmount-4 was expected to deliver superior results compared to Novo's Step-4, further enhancing Mounjaro's impressive profile.
Lilly's Mounjaro didn't experience any significant safety concerns, with gastrointestinal issues being the most often reported side effects throughout the studies. However, despite the promising efficacy data and safety profile, Lilly faces supply chain challenges. The FDA has added Mounjaro to its drug shortage database, and the supply issues for the drug's various doses are expected to persist longer than initially estimated. This poses a potential hurdle once Mounjaro receives approval for obesity treatment.
The eagerly awaited head-to-head trial, Surmount-5, will provide a decisive verdict in 2025, shedding further light on the potential winner of the obesity therapeutics battle.
BioIntel360 suggests that the battle between Mounjaro and Wegovy promises groundbreaking advancements in obesity treatment. As both companies strive to prove their drugs' efficacy and safety, patients and healthcare professionals alike eagerly await the final verdict. Whichever drug emerges victorious, it will undoubtedly mark a significant milestone in the fight against obesity, offering hope for millions around the world struggling with this chronic condition.
