FDA Declines Approval for Biovitrum’s Gout Therapy
On 29 June 2026, the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for Swedish Orphan Biovitrum AB’s biologics license application for NASP (nanoencapsulated sirolimus plus pegadricase). The CRL requested additional information on chemistry, manufacturing and controls (CMC) and identified deficiencies at the contract manufacturing facilities used for the product. The agency explicitly stated that it had no concerns regarding the therapy’s safety or efficacy.
Market Reaction
Following the FDA’s decision, Biovitrum’s shares on the Stockholm exchange fell 2.5% to SEK 454.5, representing an approximate 3% decline, while the OMX Stockholm 30 index posted a modest gain of about 0.3%.
Company Response and Next Steps
Biovitrum announced that it will meet with the FDA to discuss the feedback, determine the appropriate path toward resubmission, and work with its manufacturing partners to remediate the identified CMC deficiencies.
Product Profile and Competitive Landscape
NASP is an investigational therapy administered as an infusion once every four weeks, intended to lower uric acid levels in adults with uncontrolled gout whose condition remains poorly managed despite existing treatments. If eventually approved, NASP would compete directly with Amgen Inc.’s Krystexxa, which is currently the only FDA‑approved therapy for uncontrolled gout.
Reporting
The article was reported by Roushni Nair on Investing.com.