Product information and disease description Product description

Phase of product development

9 evidence topics · 8 sources

FDA orphan designation and approval status

“FDA Orphan Approval Status: Not FDA Approved for Orphan Indication” (opens the source at this quote in a new tab)
“Date Designated: 10/31/2012” (opens the source at this quote in a new tab)

Fast Track and Breakthrough Therapy designations

“Fast Track Designation and Breakthrough Therapy Designation by the FDA in May 2019 and December 2019, respectively.” (opens the source at this quote in a new tab)

Initial biologics application and refusal to file

“May 27, 2025” (opens the source at this quote in a new tab)
“the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review” (opens the source at this quote in a new tab)

Regulatory submission: BLA resubmitted December 2025

“December 22, 2025” (opens the source at this quote in a new tab)
“resubmitted the MOLBREEVI BLA to the FDA, with Fujifilm as the drug substance manufacturer.” (opens the source at this quote in a new tab)

Launch

No evidence found.

Advisory Committee meeting

“March 6, 2026” (opens the source at this quote in a new tab)
“an Advisory Committee meeting is not planned for the MOLBREEVI Biologics License Application (BLA)” (opens the source at this quote in a new tab)

Priority Review and extended FDA target action date

“April 15, 2026” (opens the source at this quote in a new tab)
“Priority Review” (opens the source at this quote in a new tab)
“PDUFA target action date is November 22, 2026.” (opens the source at this quote in a new tab)

European and United Kingdom regulatory applications

“August 11, 2026” (opens the source at this quote in a new tab)
“MOLBREEVI MAAs Under Review by the EMA and the U.K.’s MHRA; Decisions Expected in Q1 2027 and Q4 2026, respectively” (opens the source at this quote in a new tab)

Approval status in the second-quarter business update

“It is not approved in any indication.” (opens the source at this quote in a new tab)

European regulatory route in the horizon scan

“Centralised (EMA)” (opens the source at this quote in a new tab)