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. 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 (NYSE:NVO)'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 United Kingdom, Lilly will use one pen type for both uses against type 2 diabetes and obesity.
Britain's drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), said it could not comment on any device applications, citing commercial confidentiality.
Nearly one in three adults are obese in Britain, the highest in Europe, according to a 2019 Organisation for Economic Co-operation and Development (OECD) report.
Overweight-related illnesses account for 8.4% of health expenditure and when combined with lower labour market output, it reduces UK GDP by 3.4%, it said. Obesity is usually defined as having a body mass index (BMI) of 30 or above.
The Lilly drug already has approval for type 2 diabetes but has yet to be launched by the manufacturer in this indication in the UK.
Asked when it would be available for weight loss in Britain, Lilly would not give a 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.
NEW DRUG COULD HELP THOUSANDS
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.
David Strain, associate professor of cardiometabolic health at the University of Exeter, who sees type 2 diabetes patients in the state-run health system, urged steps against the promotion of unhealthy food as patients wait for the new drug.
“It is great that tirzepatide has been approved, but we are not going to have that in our hands soon, and the government is currently trying to distract from the fact that we are not yet implementing upstream measures to prevent obesity in the first place,” said Strain.
A spokesperson for NHS England said the National Institute for Health and Care Excellence, or NICE, is assessing the treatment.
A spokesperson for the cost-effectiveness body said that NICE planned to publish final guidance on its appraisal on tirzepatide for weight management and diabetes in March 2024.
Tirzepatide has been available under the Mounjaro brand name for type 2 diabetes since 2022 in the United States. It is not yet 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.