Imsidolimab (Quimilza) for Generalized pustular psoriasis
The FDA is expected to decide on Imsidolimab for Generalized pustular psoriasis by December 12, 2026, under a BLA from Vanda Pharmaceuticals.
What is being decided
Vanda Pharmaceuticals has a BLA under FDA review for Imsidolimab (Quimilza) in Generalized pustular psoriasis. IL-36 receptor antibody targeting generalized pustular psoriasis flares. Vanda's August 5, 2026 quarterly release refers to the product by the proposed brand name Quimilza and reaffirmed the December 12 target action date.
About the drug
Imsidolimab: fully humanized IgG4 monoclonal antibody that blocks interleukin-36 receptor signaling. Our full Imsidolimab profile covers how it works, side effects in plain language, and its trial history.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Get notified when new generalized-pustular-psoriasis trials open or existing trials change status, add sites, or update eligibility.
Frequently asked questions
When will the FDA decide on Imsidolimab?
The FDA's target decision date (PDUFA date) for Imsidolimab in Generalized pustular psoriasis is December 12, 2026, disclosed by Vanda Pharmaceuticals. The agency can act before this date and occasionally runs past it.
What is Imsidolimab being reviewed for?
Vanda Pharmaceuticals submitted a BLA for Imsidolimab in Generalized pustular psoriasis. IL-36 receptor antibody targeting generalized pustular psoriasis flares. Vanda's August 5, 2026 quarterly release refers to the product by the proposed brand name Quimilza and reaffirmed the December 12 target action date.
What happens after the Imsidolimab decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Vanda announcement. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.