Name: Imsidolimab in Generalized pustular psoriasis: Phase of product development
Published: 2026-09-14T15:39:06-04:00

Product information and disease description Product description

Phase of product development

7 evidence topics · 8 sources

Product name, regulatory status, and anticipated FDA action

“Quimilza™ (imsidolimab) BLA for GPP under review by the FDA; PDUFA target action date of December 12, 2026” (opens the source at this quote in a new tab)

Regulatory submission: BLA submitted December 2025

“In December 2025, we submitted the Biologics License Application (BLA) for imsidolimab for the treatment of GPP” (opens the source at this quote in a new tab)

“submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab” (opens the source at this quote in a new tab)

Launch: Anticipated in the first half of 2027

“We do not expect that we will be commercially launching right after the PDUFA date. There will be some lag time, but hopefully we can do that within the first half of 2027.” (opens the source at this quote in a new tab)

FDA filing acceptance

“has accepted the filing of its Biologics License Application (BLA) for imsidolimab for the treatment of Generalized Pustular Psoriasis (GPP)” (opens the source at this quote in a new tab)

Orphan drug designation: United States

“In July 2020, the FDA granted orphan drug designation to imsidolimab for the treatment of GPP based upon GALLOP clinical data.” (opens the source at this quote in a new tab)

Orphan drug designation: Japan

“Japan's Ministry of Health, Labour and Welfare (MHLW) has granted orphan drug designation to imsidolimab” (opens the source at this quote in a new tab)

Orphan designation: European Union

“its investigational drug imsidolimab has received Orphan Designation from the European Commission” (opens the source at this quote in a new tab)