[비즈한국] Wegovy (generic name: semaglutide), known as the “dream obesity drug,” is being launched in tablet form. The arrival of an “oral obesity drug” that eliminates the aversion to injections and dramatically improves convenience is expected to shake up the global obesity drug market once again.
Novo Nordisk announced on the 22nd (local time) that it has received approval from the U.S. Food and Drug Administration (FDA) for the Wegovy pill (semaglutide 25mg). This marks the first time a GLP-1 (glucagon-like peptide-1) receptor agonist for obesity treatment has been approved by the FDA in an oral formulation.
The Wegovy pill is approved for chronic weight management in adult patients with obesity or overweight, with a dosage of once daily. It also includes an indication for reducing the risk of cardiovascular disease. Novo Nordisk plans to launch the product in the U.S. in early January next year. The company also filed for approval of the Wegovy pill with the European Medicines Agency (EMA) in the second half of last year.
From Injections to Pills… Proved 16.6% Weight Loss Efficacy
The obesity treatment market is currently led by GLP-1 injectable drugs such as Wegovy and Zepbound (generic name: tirzepatide). However, fear of needles and the inconvenience of storage have acted as barriers to entry, leading to high demand for oral medications. Global pharmaceutical companies like Pfizer and Amgen have attempted to develop GLP-1 obesity drugs, but they have repeatedly failed due to lower bioavailability compared to injectables and various side effects.
The Wegovy pill has demonstrated both efficacy and safety. According to the results of the phase 3 "OASIS 4" study, which served as the basis for FDA approval, the patient group that took the Wegovy pill lost an average of 16.6% of their body weight by week 64. This is similar to the weight-loss efficacy of the existing injectable Wegovy (2.4mg). One in three clinical trial participants showed a weight reduction of 20% or more.
Safety was also analyzed to be at a level similar to the existing injection. The most common side effects reported were gastrointestinal disorders such as nausea, vomiting, and diarrhea.
Mike Douste, CEO of Novo Nordisk, emphasized, "With this approval, patients can now take a once-daily pill that provides the same weight loss efficacy as the Wegovy injection," adding, "No other oral GLP-1 treatment will be able to come close to the weight loss effectiveness of the Wegovy pill."
Will It Shake the Market Dominated by Eli Lilly?
The industry is watching to see if this approval will allow Novo Nordisk to pull ahead in the obesity drug race against Eli Lilly. Currently, the obesity treatment market is divided between Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, with recent assessments suggesting that Zepbound has been gaining momentum. In the third quarter of this year, Wegovy's global sales were $2.95 billion (KRW 4.3775 trillion), while Zepbound reached $3.6 billion (KRW 5.342 trillion).
As Novo Nordisk secures an early lead in the oral pill market, expectations are that it will not only attract new patients who are reluctant to use injections but also capture demand from those who start treatment with injections and switch to oral medication for maintenance. Eli Lilly filed a New Drug Application (NDA) for 'orforglipron' with the FDA on the 18th, and it is expected to be approved as early as the first half of next year and launched in the second half.
U.S. investment bank Goldman Sachs has projected that the global obesity treatment market will reach $120 billion (KRW 178 trillion) by 2035.