(Bloomberg) -- Novo Nordisk A/S’s weight-loss shot Wegovy gained expanded clearance as a heart drug in the UK, as the country’s regulators followed the US in broadening use of the blockbuster medicine.
UK doctors will be able to prescribe the medicine to prevent heart attacks or strokes in people who already have heart disease and are overweight or obese, the Medicines and Healthcare products Regulatory Agency said Tuesday.
Expanding Wegovy’s uses beyond obesity treatment is a crucial part of Novo’s effort to boost access and sales. Cardiovascular disease is one of the leading causes of disability and death in the UK, the agency said. The shares gained gained 1.5% at the close of trading in Copenhagen. They’ve gained 32% this year.
Novo started selling Wegovy for weight loss last year in the UK, after British patients joined waitlists for months due to limited supplies of the drug. National Health Service patients are limited to two years on Wegovy, though it’s also widely sold to self-pay patients via pharmacies such as Boots and Superdrug.
The heart disease approval is based on a large study, backed by Novo, that found Wegovy cut the risk of major heart afflictions such as heart attack and stroke by one-fifth. About 6.5% of the patients who took Wegovy had these serious heart disorders in the course of the study, compared with 8% of those who took a placebo shot.
In the US, the broader label has put insurers under increasing pressure to cover Wegovy, as well as igniting a pricing debate that will bring Novo Chief Executive Officer Lars Fruergaard Jorgensen before a Senate committee to testify in September.
The UK authority was quicker to move on the heart disease approval for Wegovy than its European Union counterpart. The MHRA granted authorization under a new process that allows a quicker assessment if another trusted regulator — in this case, the US Food and Drug Administration — has already signed off on a medicine.
(Updates with details from the fourth paragraph.)
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