UK approves Novo Nordisk's Wegovy pill

Novo Nordisk has won approval in the UK for its oral formulation of GLP-1 agonist Wegovy, consolidating the company's position in the weight-loss market as it battles for supremacy with Eli Lilly.

The green light from the MHRA medicines regulator gives patients the first alternative to injectable GLP-1 drugs – i.e. the original subcutaneous formulation of Wegovy (semaglutide) and Eli Lilly's Mounjaro (tirzepatide) – and gives Novo Nordisk a window of opportunity to build a market position for the oral version before Lilly is in a position to launch its rival oral therapy Foundayo (orforglipron).

The UK is the first country in Europe to approve the Wegovy pill, said Emil Kongshøj Larsen, Novo Nordisk's head of international operations, and only the third to give it the go-ahead after the US and the United Arab Emirates (UAE). It is likely to be approved in the EU shortly, having been recommended by the EMA's human medicines committee at its May meeting.

"Around 15 million people in the UK are living with obesity, yet only a small proportion of them have access to treatment, and we hope this approval supports increasing access to obesity care," he added.

Whilst the tablet has been approved for use in the UK, it is not currently available via the NHS as it will still have to complete an appraisal by the reimbursement authority NICE.

The MHRA approval covers the use of the new drug for adults who have a BMI of 30 or above, or who are overweight with a BMI between 27 and 30 and at least one weight-related comorbidity.

In a statement, the regulator said that the starting dose for the semaglutide tablet is 1.5 mg once daily, increasing to 4 mg, 9 mg and 25 mg with a minimum duration of one month at each dose level.

Patients currently treated privately with a 2.4 mg Wegovy injection once weekly – the majority of patients on the drug in the UK – can be transitioned straight to the 25 mg tablets oral dose if they prefer.

Prescriptions in the US growing fast

Novo Nordisk gave an update on the Wegovy pill rollout at the ADA congress earlier this month, saying total prescriptions had already exceeded three million, with a scrip filled approximately every five seconds.

The company said the rollout – with a million prescriptions filled in 12 weeks and two million in the subsequent 10 weeks – makes it "one of the strongest US pharmaceutical launches by volume on record." So far, Lilly's launch of Foundayo does not seem to be matching that performance, reaching 20,000 in its first couple of weeks on the market following its approval by the FDA at the start of April.

The prescribing data was a fillip for Novo Nordisk, which has seen its dominant position in the weight-loss market with Wegovy injection steadily eroded in the last few months by the breakneck growth of tirzepatide, which is sold as Zepbound in the US.