Eli Lilly needs approval for injection pen use in UK for weight-loss drug
Lilly says the injection device in question will be different from the pen Lilly plans to use for the weight-loss drug in the US
09 November 2023 - 17:06
by Maggie Fick and Ludwig Burger
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An Eli Lilly pharmaceutical manufacturing plant in Branchburg, New Jersey on March 5 2021. File Picture: REUTERS/Mike Segar
London — Eli Lilly said on Thursday that it had 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 US the Food and Drug Administration (FDA) 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 US company said 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 US, 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 could 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 US, but it is not available in Britain.
In October, Nice 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, the NHS has three months to make tirzepatide available to be prescribed.
The charity Diabetes UK said at the time it was seeking to better understand what supply might be available in early 2024.
Support our award-winning journalism. The Premium package (digital only) is R30 for the first month and thereafter you pay R129 p/m now ad-free for all subscribers.
Eli Lilly needs approval for injection pen use in UK for weight-loss drug
Lilly says the injection device in question will be different from the pen Lilly plans to use for the weight-loss drug in the US
London — Eli Lilly said on Thursday that it had 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 US the Food and Drug Administration (FDA) 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 US company said 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 US, 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 could 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 US, but it is not available in Britain.
In October, Nice 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, the NHS has three months to make tirzepatide available to be prescribed.
The charity Diabetes UK said at the time it was seeking to better understand what supply might be available in early 2024.
Reuters
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