Novo Nordisk’s Wegovy passes NICE checkpoint en route to blockbusterland

Novo Nordisk’s new weight loss contender Wegovy has taken another step on the road to blockbuster, thanks to the green light from England’s drug cost watchdog.

The UK’s National Institute for Health and Care Excellence (NICE) has approved Novo Nordisk’s obesity drug Wegovy. NICE 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 quotes a list price of £73.25 (around $99.08) for a pack of four pre-filled pens in the UK.

The GLP-1 drug should be prescribed as part of a “specialty weight management service”, including “multidisciplinary intakes” 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 to 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 reducing their overall calorie intake.

According to the 2019 Health Survey for England, some 28% of adults in England are obese and a further 36% are overweight.

“[Obesity] is a lifelong condition that requires medical intervention, has psychological and physical effects, and can affect quality of life,” said Helen Knight, program director at NICE’s Center for Health Technology Assessment, in a statement. “But in recent years, NICE has been able to recommend a new range of pharmaceutical treatments that have been shown that people who use them, along with changes to their diet and exercise, have been able to reduce weight.”

“We hope the availability of Wegovy on the NHS will help thousands of people with obesity,” Pinder Sahota, chief executive of Novo Nordisk UK, said in an emailed statement. In pursuit of its mission to defeat chronic disease, Novo Nordisk is “committed to bringing new and innovative treatments to drive change for people with obesity in the UK”, it continued.

Wegovy currently registers about 22,000 scripts per week in the United States, Doug Langa, executive vice president and head of North American operations at Novo, said during the company’s fourth quarter earnings call last week. Alongside Novo’s previous weight loss drug, Saxenda, Wegovy has helped get up obesity sales for 2021 by 55% to DKK 8.4 billion ($1.28 billion).

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Novo has yet to release individual sales figures for Wegovy, but Jefferies analysts estimate the drug generated around 700 million Danish kroner (about $107.2 million) in the last three months of 2021.

Despite the drug’s positive momentum, Wegovy has encountered a number of supply issues during its short time on the market. Shortly after the drug’s debut, demand was so high that Novo’s supply chain was not ready to process orders. Pharmaceutical companies typically add capacity as the launch progresses, but Novo was forced to catch up amid strong early demand.

Meanwhile, Novo said in December that Wegovy would be running out of resources in the United States after a contract manufacturer responsible for filling syringes had to halt shipments due to issues with good manufacturing practices. Novo and its partner are working on the issue and remain confident that they can meet US demand for Wegovy in the second half.

Meanwhile, Novo Nordisk has stabilized existing US supply through a combination of internal and external capabilities, as well as changing clinical lead times.

As for the UK, Novo told Fierce Pharma it is working to make Wegovy available on the NHS “as soon as possible”, although exact timelines are currently confidential.

On whether Wegovy’s supply problems in the US could spill over to the UK, Novo Nordisk said: “[l]launch plans for countries other than the United States are currently being developed and will be executed when the necessary local regulatory approvals have been obtained, access is secure in each market and sufficient supply is available to meet anticipated demand.

Editor’s Note: This story has been updated with additional comments from Novo Nordisk.

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