Posted by Michael Wonder on 10 Sep 2025
FDA accepts biologics license application for Sobi's NASP for patients with uncontrolled gout
10 September 2025 - Sobi today announced that the US FDA has accepted the biologics license application seeking approval for Nanoecapsulated Sirolimus plus Pegadricase (NASP), formerly SEL-212, for the treatment of uncontrolled gout.
The FDA has set a PDUFA, or target action date of 27 June 2026.
