The Food and Drug Administration (FDA) has approved the oral version of Novo Nordisk’s weight loss medication, Wegovy. This marks the first time a GLP-1 pill has received regulatory clearance for obesity treatment, potentially expanding access to a highly effective option for many Americans. The approval, announced on October 23, 2023, comes at a time when demand for injectable weight loss solutions is surging.
The newly approved Wegovy pill can also help reduce cardiovascular risks, similar to its injectable counterpart. Novo Nordisk plans to launch the oral medication in January 2024. In clinical trials, the highest available dose of 25 milligrams resulted in an average weight loss of approximately 14%, comparable to the results observed with the injectable form of Wegovy.
Pricing details for the oral version have not yet been disclosed. Currently, the injectable Wegovy and Eli Lilly’s Zepbound have generated significant interest, but Novo Nordisk believes a GLP-1 pill could attract an even larger patient base due to its convenience and the absence of cold storage requirements. While Novo already markets Rybelsus, another GLP-1 pill containing the same active ingredient, it is approved solely for the treatment of type 2 diabetes.
The approval of the oral Wegovy comes as Novo Nordisk faces increasing competition in the obesity market. More patients are opting for Eli Lilly’s Zepbound, highlighting the need for Novo to regain its market position. Although it remains uncertain whether the oral formulation will significantly impact Novo’s share of the obesity treatment market, the pill’s formulation presents unique challenges.
Wegovy’s active ingredients consist of large peptides, making absorption more complex and necessitating a higher dosage to achieve effectiveness. Additionally, patients must take the pill at least 30 minutes before eating in the morning.
In contrast, Lilly is developing its own GLP-1 pill, orforglipron, which is currently under FDA review and is expected to receive approval soon. Experts suggest that orforglipron, being a small molecule, may be easier to manufacture and lacks the timing restrictions associated with Wegovy. Nevertheless, early trial results indicate that orforglipron may not be as effective as the oral Wegovy.
Pricing will play a significant role in determining patient demand. Novo and Lilly have reached an agreement with the Trump administration to offer their pills for approximately $150 per month for the lowest dose through direct-to-consumer channels. This pricing strategy allows patients to purchase the medication without insurance, making it more accessible than the current cash prices for low-dose injectables. However, neither company has released information on the pricing for higher doses or what costs will be for insurance payers.
As the market for weight loss medications evolves, the approval of Wegovy’s oral form could reshape treatment options and access for individuals seeking effective solutions. The next few months will be crucial as both Novo Nordisk and Eli Lilly prepare for the launch of their oral medications.