June 26 (Reuters) – The U.S. Food and Drug Administration declined to approve Swedish drugmaker Sobi’s therapy to treat uncontrolled gout, a common form of inflammatory arthritis, the company said on Friday.
In its so-called complete response letter, the FDA requested additional data related to chemistry, manufacturing, controls and contract manufacturing facilities, the Stockholm-based company said.
Sobi said it will request a meeting with the FDA to discuss the feedback, determine the appropriate steps toward resubmission and work with the contract manufacturing organizations to address the deficiencies.
(Reporting by Sneha S K and Puyaan Singh in Bengaluru; Editing by Leroy Leo and Sahal Muhammed)
Copyright 2026 Thomson Reuters.
Photos You Should See – June 2026
Reuters
Source link