FDA Accelerates Review of Type 2 Drug Mounjaro for Weight Loss
By Arvind Sommi
Mounjaro, a drug approved in 2022 to treat type 2 diabetes, has also shown remarkable weight-loss effects, reducing trial participants’ weight by over 20%. Regulators have taken notice, granting the medication a fast-track designation for its review for the treatment of obesity.
The US Food and Drug Administration (FDA) approved tirzepatide for the treatment of type 2 diabetes in May, when Eli Lilly & Co. began marketing the medication as Mounjaro. While the drug is currently approved as a glucose-lowering therapy for type 2 diabetes, participants in the SURMOUNT-1 clinical trial on a 15mg dose of tirzepatide experienced an astonishing 22.5% reduction in body weight.
Lilly announced on Oct. 6 that the FDA granted tirzepatide a “fast track” review to be designated as a treatment for obesity. To receive this label, Lilly will be using data from the SURMOUNT-1 trial and the ongoing SURMOUNT-2 trial, which is investigating tirzepatide in people with type 2 diabetes who have excess weight or obesity.
Although the SURMOUNT-2 trial will not be completed until April 2023, the FDA’s fast-track designation allows for rolling submission of trial data. This means the FDA can review data as it comes in, instead of waiting for the entire trial to conclude first. This expedites the review process, resulting in a potentially sooner approval date.
The FDA grants these fast-track designations to medications that could fill a serious unmet medical need. With the rising rates of adult and childhood obesity, coupled with the limited options for medical treatment, tirzepatide could be a game-changer in the obesity epidemic.
Currently, one of the best glucose-lowering medications for weight management is Wegovy (semaglutide), which resulted in a 14.9% reduction in body weight – significantly lower than tirzepatide’s 22.5% reduction.
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