Apellis Pharmaceuticals said Thursday that submission of additional clinical data to the Food and Drug Administration will delay the review of its experimental treatment for geographic atrophy — a chronic eye disease and a leading cause of blindness in older people.
The FDA was set to announce an approval decision for the Apellis drug on Nov. 26. The review will now be extended by three months to February 2023.
“This was our decision,” Apellis CEO Cedric Francois told STAT, when asked if any recent interactions with the FDA suggested the original marketing application might not be strong enough to support an approval.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.
Already have an account? Log in
Already have an account? Log in
To submit a correction request, please visit our Contact Us page.
STAT encourages you to share your voice. We welcome your commentary, criticism, and expertise on our subscriber-only platform, STAT+ Connect