US FDA declines to approve Sobi's therapy for uncontrolled gout

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)

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This story was originally published June 26, 2026 at 3:28 PM.