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FDA sends Sobi a complete response letter for uncontrolled gout drug

Fri, 26 Jun 2026 16:02:38 -0400

Sobi (STO: SOBI) announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its Biologics License Application for NASP (nanoencapsulated sirolimus plus pegadricase), an investigational treatment for adult patients with uncontrolled gout.

The FDA requested additional data related to the manufacturing control strategy of NASP's biological component and identified deficiencies at contract manufacturing facilities. The agency raised no concerns regarding the clinical efficacy or safety of NASP that affect approvability.

Sobi said it plans to request a meeting with the FDA to discuss the feedback and determine steps toward resubmission, and will work with its contract

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Fri, 26 Jun 2026 15:59:00 -0400

STOCKHOLM, June 26, 2026 /PRNewswire/ --The FDA has requested additional data related to chemistry, manufacturing, and controls (CMC) and contract manufacturing facilities; no clinical safety or efficacy concerns were identified that impact approvability

Sobi to meet with FDA to discuss next steps for resubmission

Sobi® (STO: SOBI) today announced that the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the Company's Biologics License Application (BLA) for NASP (nanoencapsulated sirolimus plus pegadricase) for the treatment of adult patients with uncontrolled gout.

In the CRL, the FDA required

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Fri, 26 Jun 2026 15:59:00 -0400

Sobi to meet with FDA to discuss next steps for resubmission

In the CRL, the FDA required

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Fri, 26 Jun 2026 15:59:00 -0400

Sobi to meet with FDA to discuss next steps for resubmission

In the CRL, the FDA required

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Fri, 26 Jun 2026 15:59:00 -0400

Sobi to meet with FDA to discuss next steps for resubmission

In the CRL, the FDA required

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Fri, 26 Jun 2026 15:59:00 -0400

Sobi to meet with FDA to discuss next steps for resubmission

In the CRL, the FDA required

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Fri, 26 Jun 2026 15:59:00 -0400

Sobi to meet with FDA to discuss next steps for resubmission

In the CRL, the FDA required

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Fri, 26 Jun 2026 15:59:00 -0400

Sobi to meet with FDA to discuss next steps for resubmission

In the CRL, the FDA required

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Fri, 26 Jun 2026 15:59:00 -0400

Sobi to meet with FDA to discuss next steps for resubmission

In the CRL, the FDA required

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Fri, 26 Jun 2026 15:59:00 -0400

Sobi to meet with FDA to discuss next steps for resubmission

In the CRL, the FDA required

Sobi receives complete response letter from FDA for NASP (nanoencapsulated sirolimus plus pegadricase)

Fri, 26 Jun 2026 15:59:00 -0400

Sobi to meet with FDA to discuss next steps for resubmission

In the CRL, the FDA required

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