By Maggie Fick and Ludwig Burger
LONDON (Reuters) – Eli Lilly revealed on Thursday that it has not received the green light in Britain for the injection pen designed for its Mounjaro drug, which is intended for treating obesity and diabetes. This adds a layer of uncertainty to the timing of the product’s debut in the market.
The drug itself was given the green light for weight loss by the British regulator on Wednesday, while the U.S. Food and Drug Administration also granted approval for its broader use.
“We have submitted an alternative device presentation of tirzepatide for regulatory approval. We are continuing to work closely with relevant government agencies and are focusing on ensuring a sustainable supply,” a spokesperson for the U.S. company told Reuters in a statement.
Tirzepatide is the active ingredient in Mounjaro, and its launch is expected to trigger stiff competition with Novo Nordisk’s Wegovy injection drug in the rapidly growing weight-loss market.
The Lilly spokesperson also mentioned that the injection device in question would be different from the pen that Lilly plans to use for the weight-loss drug in the United States, where it has been rebranded as Zepbound. Within the UK, Lilly will use one pen type for both uses against type 2 diabetes and obesity.
“We would be unable to confirm the status or time lines of any potential or ongoing applications due to commercial confidentiality,” Britain’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said in response to a request for comment.
The drug already has approval for type 2 diabetes, but the manufacturer has yet to launch it for this purpose in the UK.
When asked about the availability of the drug for weight loss in Britain, Lilly would not provide a launch date.
“Before launching a new treatment Lilly needs to ensure that it can appropriately supply the medicine, considering many factors including expected demand and competitive supply,” it said in a statement.
Britain’s health secretary welcomed the prospect of a new weight-loss treatment, saying it could help thousands of people.
“Tackling obesity could help cut waiting lists and save the NHS (National Health Service) billions of pounds,” Steve Barclay said in a statement.
He said further approvals were needed before the drug can be covered by the NHS.
A spokesperson for NHS England said the National Institute for Health and Care Excellence, or NICE, would have to assess the treatment.
A spokesperson for the cost-benefit-assessment body said that NICE plans to publish final guidance on its appraisal on tirzepatide for weight management and diabetes in March 2024.
Lilly’s drug tirzepatide has been available under the Mounjaro brand name for type 2 diabetes since 2022 in the United States, but it is not available in Britain.
NICE in October published guidance on Mounjaro for treating type 2 diabetes, stating that it would be given to patients with poorly controlled diabetes who suffer from certain levels of obesity or medical conditions.
From the moment of publication, NHS has three months to make tirzepatide available to be prescribed. The charity Diabetes UK said it is seeking to better understand what supply might be available in early 2024.
(Reporting by Maggie Fick in London and Ludwig Burger in Frankfurt Editing by David Goodman and Tomasz Janowski)
