England's NICE signs off on Eli Lilly's Mounjaro after initial uncertainties

Eli Lilly has been riding the success of its new diabetes drug Mounjaro since its U.S. debut last May. Now, the company and its star medicine are set for a boost across the pond.

England’s National Institute for Health and Care Excellence (NICE) has signed off on Mounjaro (tirzepatide), coupled with diet and exercise, to treat poorly controlled Type 2 diabetes in adults. With the endorsement, the drug can be covered by the country's National Health Service (NHS). 

Around 90% of the 5 million diabetes patients in the U.K. have Type 2 diabetes, NICE said in a release, citing research from the nonprofit Diabetes UK.

According to the agency, almost 2 in 3 people with Type 2 diabetes don’t have their disease under control with current treatments. Poor diabetes control can lead to serious complications such as kidney disease, blindness and dangerous cardiovascular events.

NICE made its decision after looking at evidence showing that the med can significantly cut blood sugar and body weight compared with Novo Nordisk’s popular rival GLP-1 medicine semaglutide, traditional insulin therapy or placebo.

The nod is a draft version of the final guidance that will be published in full on Oct. 11. Mounjaro should be available on NHS England 90 days after that, pending available supply.

For Lilly, the latest recommendation is a welcome victory after NICE’s prior review didn't reach the same conclusion. Initially, the agency “saw the promise” in Mounjaro but rejected coverage for the therapy due to uncertainties in Lilly’s data, economic model and the med’s long-term benefits.  

The fast-growing medicine is still at the beginning of its blockbuster journey. Analysts at UBS last year pegged potential peak sales at $25 billion in what could be “the biggest drug ever.” Last quarter, Mounjaro generated $979 million.

Next up will be a potential approval for obesity, an application which the U.S. FDA fast-tracked last October. In the U.K., NICE is looking at that indication separately and expects to publish its guidance next March after a January committee meeting.