Novo Nordisk's Wegovy passes NICE checkpoint on course to blockbusterland

Novo Nordisk’s new weight loss contender Wegovy passed another milestone on the road to blockbusterland, courtesy of a green light from England’s drug cost watchdog.

The U.K.’s National Institute for Health and Care Excellence (NICE) has given a thumbs up to Novo Nordisk’s obesity med Wegovy. NICE’s recommendation covers the drug in adults with at least one weight-related condition and a body mass index of at least 35 kg/m2.

Wegovy carries a list price of 73.25 pounds sterling (about $99.08) for a pack of four prefilled pens in the U.K.

The GLP-1 med must be prescribed as part of a “specialist weight management service,” comprising “multidisciplinary input” such as weight management programs or specialist obesity services, including surgery. The drug can be prescribed for up to two years, NICE added.

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Clinical evidence suggests people lose more weight with Wegovy alongside supervised weight loss coaching, NICE pointed out.

NICE made its recommendation based on data from Wegovy’s Step 1 trial, which showed the drug helped patients lose 12% more of their body weight on average compared with placebo.

Wegovy works by suppressing a patient’s appetite. It does this by mimicking the hormone glucagon-like peptide-1, which is released after eating. The hormone makes people feel full, causing them to eat less and reduce their overall calorie intake.

Some 28% of adults in England are obese, and another 36% are overweight, according to the 2019 Health Survey for England.

“[Obesity] is a lifelong condition that needs medical intervention, has psychological and physical effects, and can affect quality of life,” Helen Knight, program director in the center for health technology evaluation at NICE, said in a statement. “But in recent years NICE has been able to recommend a new line of pharmaceutical treatments which have shown that those people using them, alongside changes to their diet and exercise, have been able to reduce their weight.”

“We are hopeful that Wegovy being made available on the National Health Service (NHS) will help thousands on people living with obesity,” Pinder Sahota, general manager of Novo Nordisk UK, said in an emailed statement. In pursuit of its mission to defeat chronic conditions, Novo Nordisk is “committed to bringing new and innovative treatments to drive change for people living with obesity in the UK,” he continued.

Wegovy is currently charting about 22,000 scripts per week in the U.S., Doug Langa, executive vice president and head of Novo’s North American operations, said on the company’s fourth-quarter earnings call last week. Alongside Novo’s earlier weight-loss med Saxenda, Wegovy helped lift obesity sales for 2021 by 55% to 8.4 billion Danish krone ($1.28 billion).

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Novo hasn’t broken out Wegovy’s individual sales figures yet, but Jefferies analysts estimate the drug generated about 700 million Danish krone (about $107.2 million) for the last three months of 2021.

Despite the drug's positive momentum, Wegovy has brushed up against a number of supply issues during its short run on the market. Quickly after the drug’s debut, demand was so high that Novo’s supply chain wasn’t ready to handle orders. Pharma companies typically add capacity as a launch progresses, but Novo was forced to play catch up amid a surge of early demand.

Meanwhile, Novo in December said Wegovy would run short in the U.S. after a contract manufacturer in charge of syringe filling had to halt deliveries over issues with good manufacturing practices. Novo and its partner are working on the issue and remain confident they can meet U.S. demand for Wegovy in the second half of the year.

In the meantime, Novo Nordisk has stabilized existing U.S. supply through a mix of internal and external capacity, plus a change in clinical timelines. 

As for the U.K., Novo told Fierce Pharma that it's working to make Wegovy available on the NHS “as soon as possible,” though exact timelines are currently confidential.

As for whether Wegovy’s U.S. supply woes could carry over to the U.K., Novo Nordisk said “[l]aunch plans for countries outside the US are currently being developed and will be executed when the necessary local regulatory approvals are obtained, access is secured in each market and enough supply is available to meet the anticipated demand.”

Editor's note: This story was updated with additional comments from Novo Nordisk.