Following the news that Eli Lilly’s Zepbound (tirzepatide) has received the US Food and Drug Administration (FDA) approval;

Sara Reci, MSc, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:

“Tirzepatide, which is on the market for type 2 diabetes (T2D) as Mounjaro, has received the brand name Zepbound for its use in obesity and in overweight patients who have one or more weight-related comorbidities. Previously, Mounjaro was prescribed off-label for weight loss, so this approval has been long anticipated by both physicans and patients alike, who are eager to get their hands on the newest GLP-1 agonist drug. Zepbound is Eli Lilly’s first drug which is indicated for obesity, and its arrival to the obesity space is set to raise the competition for Novo Nordisk’s Wegovy (semaglutide) as a gold-standard therapy.

“Zepbound is a game changer, with data from Eli Lilly’s Phase III trial, SURMOUNT-1 (NCT04184622) showing that with Zepbound, patients with overweight or obesity achieved up to 22.5% weight loss. By 2031, in the US, Zepbound is forecast to reach sales of $4,1 billion, gradually approaching the forecasted sales of $8.1 billion for Wegovy, according to GlobalData.

“Nonetheless, in the US, one of the hurdles faced with prescribing therapies for obesity is insurance coverage, caused by the fact that obesity is generally seen as a lifestyle choice rather than a chronic disease, despite the American Medical Association (AMA) recognizing that obesity is a chronic disease in 2013. However, GlobalData assumes that coverage for Zepbound will be of a similar nature to the coverage available for Wegovy, for which patients usually must meet further criteria including a specified duration for the reimbursement of therapy, and specialist use, among others.

“The need for therapies with better efficacy, which provide better weight loss benefits is an area that pharmaceutical companies continue to focus on for this indication, that is anticipated to reach a value of $27.6 billion in the US by 2031, according to GlobalData patient-based forecast. While Novo Nordisk has faced manufacturing hurdles, and consequently supply shortages, with semaglutide, Eli Lilly’s Mounjaro is also on the FDA’s drug shortage list. However both companies have invested into manufacturing to overcome these hurdles due to the mounting use of their GLP-1s. Nonetheless, it is anticipated that the competition between Eli Lilly and Novo Nordisk to win patient shares for this indication will be fierce and one to watch out for.”