Novo Nordisk shares climbed nearly 4% on Friday after Britain’s health regulator approved a higher dose of Wegovy for obesity treatment. The Medicines and Healthcare Products Regulatory Agency cleared a maximum weekly dose of 7.2 milligrams.
Novo Nordisk A/S, NVO
The new dose triples the previous 2.4 mg limit. Patients must take it as three separate injections.
The approval only applies to adult patients with obesity. Overweight patients with a BMI below 30 cannot use the higher dose.
Those using Wegovy to reduce cardiovascular risk are also excluded from the higher dosing option. Patients must remain on the standard 2.4 mg dose for at least four weeks before escalating.
Novo CEO Mike Doustdar explained the company’s strategy at the J.P. Morgan Healthcare conference this week. The company initially took a cautious approach with semaglutide development.
They brought the 2.4 mg dose to market first after studies showed 15-16% weight loss. Later trials revealed the 7.2 mg dose could deliver around 20% weight loss.
This higher weight loss matches newer competitor medications. The stepped-up dose maintains semaglutide’s established benefits for the heart, kidneys and other organs.
The company launched its oral Wegovy pill in the U.S. on January 5. IQVIA data released Friday showed 3,071 prescriptions in the first four days.
These figures only capture retail prescriptions. They don’t include prescriptions filled through Novo’s online NovoCare Pharmacy.
Barclays analysts noted actual prescription numbers will be higher. Berenberg analysts project the oral pill could bring in roughly $1 billion this year.
Higher-than-expected sales could offset challenges like U.S. price cuts and patent expiries. The company awaits a ruling from Britain’s regulator on the oral version.
Eli Lilly’s tirzepatide has gained market share in the weight-loss drug space. This competition has pushed Novo to find ways to stay competitive.
The oral version represents one step in that direction. Emil Kongshoj Larsen, Novo’s executive vice president for international operations, spoke at the conference this week.
He said high-dose Wegovy launches are the top priority outside the U.S. this year. The company views these launches as critical for entering new markets with strong weight-loss messaging.
The approval expands the arsenal of GLP-1 drugs available in Britain. Regulators worldwide continue expanding dosing options for this class of medicine.
Semaglutide is sold under both the Wegovy and Ozempic brand names. Ozempic received approval for type 2 diabetes treatment in 2017.
Wegovy gained approval for chronic weight management in 2021. The U.K. expects a final decision on regulatory approval for the oral version by year-end.
Lilly stock slipped 0.3% while Novo shares gained. Prescription data showed encouraging signs for the oral Wegovy launch.
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