Eli Lilly and Co said on Thursday it plans to start a rolling submission to the U.S. Food and Drug Administration (FDA) this year to get an approval for its obesity drug tirzepatide.
The data it will submit will include that from two late-stage trials, one of which is expected in April.
The FDA has also granted “Fast Track” designation for the drug to treat obesity or overweight with weight-related comorbidities in adults, under which the regulator expedites the review of medicines to treat serious conditions and fill an unmet medical need.
Obesity is a major health concern in the United States, with the disease estimated to have affected more than 40% of the population and cost nearly $173 billion annually, as per data from the Centers for Disease Control and Prevention.
Shares of Eli Lilly were up 1.4% in premarket trade.
The FDA had already approved tirzepatide, under the brand name Mounjaro, for the treatment of Type 2 diabetes in May.
The company in April had reported that the drug had achieved a goal of helping patients lose more than 20% of their weight in a late-stage clinical trial, prompting analysts to increase their peak sales estimate for the drug.
Wells Fargo analyst Mohit Bansal had then raised his estimate for tirzepatide’s sale as an obesity drug to $7.5 billion from $4 billion earlier while expecting total sales of the drug’s franchise hit $18 billion at peak.
Tirzepatide’s competition currently is a drug by Novo Nordisk, which is sold as Ozempic for treatment of Type 2 diabetes and Wegovy for use against obesity. (Reporting by Leroy Leo in Bengaluru; editing by Uttaresh.V)