With the approval of the first GLP-1 oral weight-loss drug by US regulators Novo Nordisk , the Danish pharmaceutical giant The tablet version of Wegovy marks the beginning of a new era in obesity drug revolution, with the potential for further expansion of this type of drug.
Following the announcement, the company's stock rose by about 10% in after-hours trading, before the gains narrowed slightly to 9.5%.
This approval is a crucial victory for Novo Nordisk . Previously, the company had faced stiff competition from Eli Lilly in the weight-loss drug market. The company faced intense competition, and its stock price was under pressure at one point during the year.
Planned to launch in January next year
Novo Nordisk said Monday it plans to begin selling the new pill in the U.S. in early January, with a cash price of $149 per month for the initial dose. The company also stated that for those with insurance... For patients, the monthly cost can be as low as $25 if all doses are covered.
This tablet contains 25 mg of semaglutide, the same active ingredient found in the injectable Wegovy and Ozempic, and will be marketed under the brand name "Wegovy". Novo Nordisk previously marketed Rybelsus, an oral semaglutide medication used to treat type 2 diabetes.
The FDA approval was based on the results of a Phase 3 clinical trial called Oasis 4. The trial data showed that patients taking a daily dose of 25 mg experienced an average weight loss of approximately 16.6% after 64 weeks . This significant weight loss effect provides strong support for the drug's efficacy.
According to Novo Nordisk, FDA approval also means that the drug can be used to reduce the risk of major cardiovascular events (such as death, heart attack, or stroke) in obese adults with a history of cardiovascular disease.
In an interview, Dave Moore, Executive Vice President of Operations for Novo Nordisk in the United States, stated:
"Through years of research, we have found that the emergence of oral medications can indeed attract, activate, and motivate different groups of people to seek treatment. They can discuss with their doctors whether this therapy is suitable for them."
“We are excited to provide people with an option and to ensure that we can make this drug as readily and quickly available as the injectable drugs we have always offered.”
A much-needed victory
BMO Capital Markets analyst Evan Seigerman stated in a report that the approval of Novo Nordisk's GLP-1 weight-loss tablets is "undoubtedly a much-needed victory for the company at a time when it is facing recent challenges in maintaining its dominant market share in incretins."
Earlier this year, Eli Lilly gained a significant market share with its blockbuster weight-loss injectable, Zepbound, which has been shown to be more effective than Novo Nordisk's Wegovy.
“Novo Nordisk is likely to leverage its first-mover advantage to attract patients who prefer the convenience and comfort of oral administration,” Seghman said. However, he also noted that the market is “changing rapidly, and competing products are under development,” and that Eli Lilly ’s oral drug Orforglipron “is about to be approved.”
Wall Street believes the weight-loss drug market has significant room for future growth. Goldman Sachs Analysts said in August that weight-loss drugs could account for 24% of the global weight-loss drug market by 2030, or about $22 billion.
(Article source: CLS)
