Conditional FDA Approval Puts Wegovy on Watch

US regulator clears Novo Nordisk drug for MASH, but continued approval to depend on long-term trial data

17 Aug 2025

The landscape of metabolic medicine shifted sharply on August 15, 2025, when the FDA granted accelerated approval to Novo Nordisk's semaglutide, marketed as Wegovy, for treating metabolic dysfunction associated steatohepatitis (MASH). While Wegovy is the first GLP receptor agonist approved for MASH, it becomes the second overall drug authorized for the disease, following the March 2024 approval of resmetirom (Rezdiffra) from Madrigal Pharmaceuticals.

Wegovy's clearance is based on interim data from Part 1 of the pivotal Phase 3 ESSENCE trial, which showed a significant reduction in liver inflammation. However, the drug's long-term future in this space hangs on Part 2 of the trial, with confirmatory results expected by 2029, that must demonstrate clear clinical benefits like delayed progression to cirrhosis or liver failure.

This regulatory green light is more than a clinical milestone. It redefines the scope of GLP therapies, moving them beyond weight loss and diabetes into the realm of liver disease. For Novo Nordisk, it opens a new market, but the pressure is intense. Should Part 2 fail to show compelling outcomes, the FDA could revoke the approval.

Rival pharmaceutical companies now face heightened urgency. Eli Lilly, whose GLP pipeline includes candidates aimed at NASH and obesity, will likely accelerate its efforts. Meanwhile, Madrigal, the first to market with Rezdiffra, must now defend its lead against a therapy backed by the momentum of the GLPIclass.

Experts are both excited and cautious. "This is a major advance for a patient population with historically limited options," said one hepatologist. "But the high cost and delayed proof of long-term benefit complicate payer decisions." Insurers are already signaling that coverage will involve tight restrictions, potentially limiting initial access.

Still, Wegovy's entry into liver disease therapy reinforces the rise of GLPIS as foundational treatments across chronic conditions. From diabetes to cardiovascular care and now MASH, these drugs are reshaping medical strategies, investment priorities, and treatment pipelines.

If Part 2 of ESSENCE Phase 3 delivers on expectations, Wegovy could redefine the standard of care in liver disease. For now, the FDA's approval stands as both a victory and a challenge, a vote of confidence in the science and a demand for proof that the benefits will last.