By Maggie Fick and Ludwig Burger
LONDON (Reuters) -Eli Lilly on Thursday said it has not yet gained approval in Britain for the injection pen it plans to use for its Mounjaro drug against obesity and diabetes, adding to uncertainty over timing of the product’s launch.
The drug itself was cleared for weight loss by the British regulator on Wednesday, when the U.S. the Food and Drug Administration also gave its go-ahead for the wider 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 name of the active ingredient in Mounjaro. A launch is expected to touch off fierce competition with Novo Nordisk’s Wegovy injection drug in a booming weight-loss market.
The Lilly spokesperson added 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 was 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 a response to a request for comment.
The drug already has approval for type 2 diabetes but has yet to be launched by the manufacturer in this indication in the UK.
When asked when the drug would be available for weight loss in Britain, Lilly would not give 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.
For his part, 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, saying 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 at the time it is seeking to better understand what supply might be available in early 2024.
(Reporting by Maggie Fick in London and Ludwig Burger in FrankfurtEditing by David Goodman and Tomasz Janowski)