FRANKFURT, Germany: Eli Lilly (LLY.N) Thursday said it would bring the Mounjaro drug against obesity and diabetes to British patients within weeks after getting clearance for pre-filling it into an injection pen.
In a statement, the US drugmaker added the go-ahead from the Medicines & Healthcare products Regulatory Agency (MHRA) would make United Kingdom the first major market to be supplied with the drug in the multi-shot pen for added convenience, branded as Kwikpen.
“This will enable Lilly to begin supply to the UK within weeks,” said head of UK and Northern Europe at the drugmaker, Laura Steele.
MHRA interim executive director for healthcare quality and access, Julian Beach, said the pen would allow for convenient use and be good for a month’s treatment of one subcutaneous shot per week.
The medicine itself was cleared for weight loss by the UK regulator in November last, when the US Food and Drug Administration also gave its approval for the wider use under the Zepbound brand. The US drugmaker put the UK product launch on hold while the injector pen was still under regulatory review.
Tirzepatide is the active ingredient in Mounjaro, which will compete with Novo Nordisk’s (NOVOb.CO), opens new tab Wegovy (semaglutide) injection drug in a booming weight-loss market. Both are cleared for weight loss in combination with a reduced-calorie diet and increased physical activity.
The company previously said the injection device would be different from the pen Lilly uses for the weight-loss drug in the USA.
The company has also said that the pen would be for both type 2 diabetes and obesity patients in the UK. The class of drugs that Mounjaro and Wegovy belong to was originally developed to treat type 2 diabetes but was found to also promote weight loss by suppressing appetite and slowing down digestion.
Other European markets – Switzerland, Germany and Poland – have seen Mounjaro launched before in UK. In those countries, the drug has for now been packaged in vials and patients need to draw the medication into syringes before injection.
Lilly hoped to get the go-ahead in Europe to pre-fill the Kwikpen with Mounjaro by the middle 2024.