EU to review Lilly’s multi-dose pen for Mounjaro on heels of UK launch

Eli Lilly

EU to review Lilly’s multi-dose pen for Mounjaro on heels of UK launch

Published: Feb 20, 2024

By Tristan Manalac


A European Medicines Agency committee is scheduled to deliberate on extending the market authorization for Eli Lilly’s Mounjaro (tirzepatide) to include its multi-dose, pre-filled KwikPen, according to a draft agenda of its upcoming meetings published on Monday.

Lilly’s extension application seeks to add six new strengths of Mounjaro—including its 2.5-, 5-, 7.5-, 10-, 12.5- and 15-mg doses—each to be used with the KwikPen, which can deliver four weekly subcutaneous injections. Mounjaro’s label and package leaflet will be updated accordingly, pending the decision of the European Medicines Agency’s Committee for Medicinal Products for Human Use .

The committee’s meetings are set to take place from Monday through Thursday.

The EMA’s review comes a week after Mounjaro launched in Britain, making it Lilly’s fourth European launch of the top-selling diabetes drug, following Germany, Switzerland and Poland, according to Reuters. British pharmacies have already started fulfilling orders for Mounjaro, with some reporting tens of thousands of patients on their waitlists.

Mounjaro’s active ingredient is tirzepatide, a GLP-1 receptor agonist that works by mimicking the GLP-1 hormone to activate its corresponding receptor, inducing the pancreas to secrete insulin in response to blood glucose levels. Mounjaro is indicated for type 2 diabetes but has been used off-label to treat obesity.

In November 2023, the FDA approved tirzepatide for chronic weight management—for which it carries the brand name Zepbound—formally putting Lilly in the highly lucrative obesity market, which some analysts forecast could reach $150 billion to $200 billion in value in the coming years.

Locked in a heated battle with Lilly in the obesity market is Novo Nordisk, whose GLP-1 receptor agonist semaglutide was approved for weight management nearly two years earlier, in June 2021, under the brand name Wegovy. Semaglutide is also approved as Ozempic, which is indicated for type 2 diabetes.

Despite the staggering financial potential of the obesity market, Novo and Lilly are held back by supply constraints with both companies struggling to meet the rapidly growing demand for their respective weight management medicines. In January 2024, the World Health Organization flagged the global GLP-1 receptor agonist shortage and the resulting rise in counterfeit and compounded products.

Both companies have taken steps to try and meet the market’s demand. In November 2023, Novo announced a $6 billion investment to increase its manufacturing capacity in Denmark. Last month, the Danish drugmaker dropped $16.5 billion to buy CDMO giant Catalent in an effort to boost manufacturing capabilities for its weight-loss products.

Lilly announced in its earnings call earlier this month that it was also bumping up its manufacturing capacities to ensure the infrastructure is ready in anticipation of its next-generation oral obesity drug clearing clinical trials.

Source: BioSpace