European regulator recommends Mounjaro for weight management
European advisers recommended widening Mounjaro's approval to include weight loss, a step that could ease prescribing there, while US patients already have an approved version sold as Zepbound.
Europe's medicines regulator said on Friday that its human medicines committee recommended Eli Lilly's diabetes drug Mounjaro also be approved as a weight-loss treatment [1]. The recommendation came two days after US and UK regulators both cleared the drug for weight loss [1].
Mounjaro, known scientifically as tirzepatide, has been sold to treat type 2 diabetes since 2022 [1]. The European Medicines Agency committee's recommendation goes next to the European Commission, which makes the final decision but almost always follows the EMA's guidance, according to STAT News [2]. The change in marketing authorization has not yet been granted, the EMA said [1]. The recommendation concerns Mounjaro's existing European authorization, rather than a separate approval under a second brand name [1][2].
Tirzepatide is part of an emerging class of drugs that target receptors of the GLP-1 hormone and sometimes other molecules, and that have had dramatic effects on weight loss, STAT reported [2]. Doctors had been prescribing the diabetes drug off-label for obesity, and a specific authorization could streamline the process of getting the medicine, according to STAT [2]. Reuters reported that Mounjaro had increasingly been used off-label for weight loss while the obesity approval was pending [1].
Weight-loss percentages from Lilly's trials, pricing, and how European health systems might cover the drug for weight management have not been reported.
In the United States and the United Kingdom, regulators gave the drug a green light as a weight-loss treatment on Wednesday, Nov. 8, 2023, and it will be sold under the brand name Zepbound for the expanded label [1]. Zepbound will be on US shelves later this month, and in the UK "sooner rather than later," the company said [1].
Why it matters for patients
For people in the United States, the practical news is the US approval under the brand name Zepbound, not the European recommendation [1]. Mounjaro remains the brand used for type 2 diabetes; the same molecule cleared for weight loss carries a different name in the US market [1].
The European action matters in a different way. Off-label prescribing lets doctors use an approved medicine for a condition it was not formally authorized to treat, but a specific authorization can make that use more straightforward [2]. For patients in Europe, that could change how easily the drug is prescribed for weight management if the European Commission grants the change [2].
What has not been reported is whether or how insurers, government health programs, or pharmacy benefit managers in any market will cover tirzepatide for weight loss. A regulatory recommendation on its own does not set coverage, price, or supply.
What happens next
The European Commission has not yet issued its final decision on the marketing authorization change, and no date for that decision was given [1][2]. In the US, Zepbound is expected on shelves later in November 2023, and the company said the UK launch would come "sooner rather than later" [1]. A committee recommendation is not a final approval, and European regulators have not said when the drug would become available for weight management there if the change is granted [1].
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