Jan 16 (Reuters) – Britain’s health regulator approved a maximum weekly dose of up to 7.2 milligrams of Novo Nordisk’s blockbuster weight-loss drug Wegovy on Friday, to be administered as three separate injections for patients with obesity.
Novo’s Denmark-listed shares jumped nearly 6% on Friday, rebounding from a 3.5% decline in the previous session, while its U.S.-listed shares rose 4.7% in premarket trading.
The higher dose, cleared by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on January 6, broadens treatment choices for patients and physicians beyond the current 2.4 mg limit.
The authorisation for the drug, chemically known as semaglutide, covers only patients with a body mass index of 30 or higher using the drug for weight management alongside diet and exercise.
Novo’s chief executive Mike Doustdar said on Tuesday that the company had initially taken a cautious approach while developing semaglutide, opting to bring the 2.4 mg dose to market after studies showed it delivered around 15%–16% weight loss.
Subsequent trials, however, showed that a stepped-up dose of 7.2 mg could deliver around 20% weight loss, comparable with newer rival medicines, without abandoning semaglutide’s established benefits for the heart, kidneys and other organs, he said.
“Medicine, to a large extent, often is dose dependent. And you just dial little bit higher, you get more effect,” the CEO said at the J.P. Morgan Healthcare Conference.
The approval adds to the growing arsenal of GLP-1 drugs available in Britain as regulators worldwide expand dosing options for this class of medicines that has reshaped pharmaceutical markets.
The Danish drugmaker is also awaiting a ruling from Britain’s medicines regulator on the easier-to-administer pill version of its weight-loss treatment, which has already been approved in the U.S.
The MHRA said on Friday the tripled dose does not apply to overweight patients with a BMI below 30 or those using Wegovy to reduce cardiovascular risk, and patients must be on the standard 2.4 mg dose at least for four weeks before escalating.
(Reporting by Mrinalika Roy and Yamini Kalia in Bengaluru; Editing by Sonia Cheema and Devika Syamnath)