MRK · 10-Q · 2026Q2 · Full report

Lagevrio U.S. Market Transition

Merck & Co., Inc. · 2026-08-07 · Importance 37 · Surprise 42 · In source text

Lagevrio remains available in the U.S. under an Emergency Use Authorization for certain adults with mild to moderate COVID-19 who are at risk of progressing to severe disease. The U.S. EUA is scheduled to terminate on June 29, 2027 after the Secretary of HHS determined that pandemic circumstances no longer justify emergency-use authorization. Merck does not anticipate FDA approval of the Lagevrio New Drug Application before termination and is working with the FDA on disposition of U.S. inventory by that date.

Key facts

• Lagevrio sales decreased 95% and 82% in the second quarter and first six months of 2026, respectively; U.S. sales of Lagevrio were $18 million in the first six months of 2026 and the Company expects the sales decline to continue during 2026. source
• The Secretary of HHS provided advance notice on June 29, 2026 that the declaration supporting EUAs for Lagevrio and certain other COVID-19 products will terminate effective June 29, 2027, and Merck is working with the FDA to develop a plan for disposition of Lagevrio in the U.S. by that date. source

Impact estimates