FDA approves Wegovy pill for weight loss, providing an oral option

In a significant development for weight-loss treatments, the U.S. Food and Drug Administration (FDA) has approved an oral version of Novo Nordisk’s Wegovy, offering patients a daily pill alternative to the injectable version. The newly approved pill contains semaglutide, the same active ingredient found in the injectable Wegovy and diabetes drug Ozempic. According to Novo Nordisk, the pill will be made available by prescription in the United States starting in January.

Comparable Weight Loss Results to Injections

Clinical trials have shown that the Wegovy pill delivers weight loss results comparable to its injectable counterpart. Over the course of 64 weeks, patients taking the pill achieved an average weight loss of 14% of their body weight, while those on a placebo experienced a mere 2% reduction. For comparison, the injectable version’s primary trial demonstrated an average weight loss of approximately 15%.

While the pill provides a more convenient alternative to injections, it does come with certain requirements for use. Patients must take it on an empty stomach with a small amount of water, followed by a 30-minute period during which no food, drink, or other medications can be consumed.

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Side Effects and Treatment Costs

As with other drugs in the GLP-1 category, the Wegovy pill may produce gastrointestinal side effects, including nausea and vomiting, which were the most frequently reported issues during clinical trials. Approximately 7% of participants in the trials discontinued the pill due to side effects, slightly higher than the 6% reported among placebo users.

Regarding cost, Novo Nordisk has announced a starting price of $149 for the initial dose of the pill for uninsured patients. Higher doses will likely cost more, although the company has not yet disclosed specific pricing. Patients with insurance coverage are expected to pay lower out-of-pocket costs through reduced copayments.

Competition in the Oral GLP-1 Market

The Wegovy pill is entering an emerging market for oral GLP-1 weight-loss medications. Eli Lilly is also preparing to launch its oral alternative, orforglipron, which is anticipated to receive FDA approval by summer. Unlike the Wegovy pill, orforglipron does not require fasting or restrictions on food intake, making it more flexible for patients. Eli Lilly’s trials showed orforglipron delivered an average weight loss of about 11% over 72 weeks at its highest dose.

Experts believe oral options like these may appeal to individuals who are hesitant to use injections, particularly for long-term weight maintenance.

Broader Health Implications and Ongoing Scrutiny

In addition to weight loss, researchers are closely observing potential broader health benefits of GLP-1 drugs, including reductions in cardiovascular risk, improvements in liver function, and a positive impact on sleep apnea. However, the treatment class has also faced scrutiny. Earlier reports highlighted concerns about a possible link between semaglutide-based medications, like Wegovy and Ozempic, and a rare eye condition called nonarteritic anterior ischemic optic neuropathy (NAION).

As treatment options expand in the increasingly competitive weight-loss drug market, doctors advise that decisions will continue to hinge on considerations of effectiveness, safety, tolerability, and cost. The approval of Wegovy’s pill format marks a notable step in providing more choices for patients seeking weight-loss solutions.

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