Does Higher Dose Of Wegovy Result In More Weight Loss? Novo Nordisk Seeks European Approval

Novo Nordisk A/S NVO on Tuesday announced that it has submitted an application to the European Medicines Agency (EMA) for approval of a new, higher dose of its obesity treatment, Wegovy (subcutaneous semaglutide 7.2 mg).

The submission is based on clinical data from the STEP UP and STEP UP T2D trials, investigating the efficacy and safety of semaglutide 7.2 mg in adults with obesity in STEP UP, and adults with obesity and type 2 diabetes in STEP UP T2D.

In the STEP UP trial, the new dose of Wegovy (semaglutide 7.2 mg) demonstrated a substantial average weight loss of 21% in people with obesity, with a third of participants losing 25% or more of their body weight compared with placebo.

Also Read: Wegovy, Zepbound Prices Drop, But Most Patients Still Can't Afford Long-Term Use: ‘Coverage Is Not The Same As Access,' Says Expert

Data also indicated that semaglutide 7.2 mg had a well-tolerated safety profile consistent with semaglutide 2.4 mg and the previous Novo Nordisk semaglutide trials.

Data from clinical trials also point to a slightly higher risk of developing the condition in people taking semaglutide compared with people taking a placebo (a dummy treatment).

In June, EMA's safety committee (PRAC) concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic optic neuropathy (NAION), an eye condition that may cause vision loss.

After reviewing all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials, post-marketing surveillance and the medical literature, the committee concluded that NAION is a very rare side effect of semaglutide (meaning it may affect up to 1 in 10,000 people taking semaglutide).

Wegovy Vs. Mounjaro

Novo Nordisk launched Wegovy (semaglutide) in India in June to compete with Eli Lilly and Co. LLY.

Novo Nordisk told Reuters that Wegovy is available in 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg doses. The first three will cost 4,336 rupees ($50.7), and the monthly cost will be 17,345 rupees ($201.4), similar to Eli Lilly's Mounjaro.

Some of Novo Nordisk's executives say the company allegedly ignored internal warnings that it was unprepared to launch Wegovy.

Wegovy, approved in the U.S. in mid-2021, marked a major advancement in obesity treatment and helped Novo generate $46 billion in net profit since then.

But the company has struggled to keep pace with Lilly's Zepbound, which has surpassed Wegovy in weekly new prescriptions this year.

Price Action: NVO stock is up 1.43% at $70.32 at the last check on Tuesday

Read Next:

• Wolfspeed Stock Continues To Surge: What's Driving The Momentum?

Photo by Tobias Arhelger via Shutterstock