FDA Approves Cheaper Oral Wegovy Pill for US

The US Food and Drug Administration has cleared the oral formulation of Wegovy for use in the United States. This approval introduces the first pill-based GLP-1 drug designated specifically for weight management.

Novo Nordisk announced the development on Monday, highlighting the pill's once-daily dosing as a convenient alternative to the weekly injection. The medication retains the active ingredient semaglutide, ensuring continuity in therapeutic effects.

Launch Timeline

The company anticipates availability in early January through standard pharmacies and select telehealth platforms. This timing aims to meet growing patient needs for accessible treatment options.

Details on insurance coverage and savings for higher doses will follow closer to the rollout, allowing eligible patients broader access.

The starting dose of 1.5 milligrams for the Wegovy pill is set at $149 per month with applicable savings offers. This pricing undercuts the injectable version's list price of approximately $1,350 monthly prior to any insurance or discounts.

Such affordability could expand access for individuals managing obesity or related conditions. Novo Nordisk plans to provide further information on options for escalating doses as the launch approaches.

Accessibility Channels

Distribution will occur via pharmacies and telehealth providers, facilitating easier obtainment without in-person visits for prescriptions.

• Pharmacies for direct pickup
• Telehealth for remote consultations
• Savings programs for cost reduction

This structure addresses barriers often encountered with injectable therapies.

In a late-stage clinical trial involving over 300 patients, the oral Wegovy led to an average 16.6% body weight loss over roughly 64 weeks among those adhering to treatment. These outcomes align closely with results from the injectable counterpart.

The pill is indicated for adults with obesity or those overweight with at least one weight-related health condition. Additionally, it supports reduction in serious cardiovascular events, including heart attacks and strokes, for qualifying patients.

Side Effects Profile

Reported adverse effects, such as nausea, diarrhea, and vomiting, occurred at rates similar to the injection. Novo Nordisk emphasized the comparable safety profile in its statements.

Patients should consult healthcare providers to assess suitability based on individual health factors.

Demand for GLP-1 weight-loss drugs like Wegovy and Ozempic has increased substantially in recent years, despite elevated costs. A survey by the health policy research group KFF conducted online and by phone with more than 1,300 adult Americans in late October and early November revealed that 12% are currently using such medications for weight loss, diabetes, or other chronic conditions.

This figure represents a rise of about six percentage points from 18 months earlier, indicating broader adoption.

Affordability Challenges

However, cost remains a hurdle: approximately half of users reported difficulty affording these drugs, even with insurance coverage. The introduction of a lower-priced pill option may alleviate some financial pressures.

• 12% usage rate among US adults
• Six-point increase over 18 months
• Half of users face affordability issues

In conclusion, the FDA's approval of the Wegovy pill marks a pivotal advancement in weight management therapies, offering enhanced convenience and reduced costs. As launch nears, it holds potential to further drive utilization while addressing persistent access barriers in the evolving landscape of GLP-1 treatments.