ABBV · 10-Q · 2026Q3 · Full report

Regulatory Risk

AbbVie Inc. · 2026-11-03 · Importance 53 · Surprise 60

The Inflation Reduction Act of 2022 has and will continue to have a significant impact on AbbVie’s business. In January 2026, CMS selected Botox as one of 15 medicines subject to government-set prices in Medicare Parts B and D beginning in 2028. On October 29, 2026, the U.S. District Court for the District of Columbia vacated the selection and enjoined CMS from publishing a maximum fair price for Botox. The ruling is subject to appeal by the government.

Key facts

• In April 2026, the FDA issued a Complete Response Letter for trenibotulinumtoxinE for moderate-to-severe glabellar lines, requesting additional manufacturing-process information but identifying no safety or efficacy concerns and requesting no additional clinical studies. source
• In June 2026, the European Commission approved Maviret for acute hepatitis C infection in adults and children aged 3 years and older. source
• AbbVie anticipated several regulatory submissions, approvals, and key clinical-trial data readouts in the next 12 months. source