Abliva’s Lead Candidate KL1333 Receives FDA Fast Track Designation
Abliva AB (Nasdaq Stockholm: ABLI) a clinical-stage company developing drugs for the
treatment of rare and severe primary mitochondrial disease, today announced that the
company’s lead candidate KL1333 has received Fast Track designation from the U.S. Food
and Drug Administration (FDA), facilitating its clinical development and path forward to
market.
Abliva’s lead drug candidate KL1333 is currently being evaluated in the FALCON study, a
global, potentially registrational, Phase 2 study in mitochondrial disease patients. Dosing was
initiated in June this year, and an interim analysis is expected towards the middle of 2024.
The FDA has now granted KL1333 Fast Track designation. This designation gives Abliva the
possibility for more frequent meetings and written communication with the FDA. In addition, it
will allow Abliva to receive continuous feedback on each section of the New Drug Application
(NDA) (for sale and marketing in the U.S.) for KL1333, with expedited review and accelerated
approval if certain criteria are met.
“The Fast Track designation is a quality stamp for our lead candidate and will facilitate our
regulatory interactions in the U.S. This designation is one more important step forward as we
prepare for a favorable interim analysis on the path towards bringing a new therapy to patients
in this area of extremely high unmet medical need”, said Ellen Donnelly, CEO.
For more information, please contact:
Catharina Johansson, Deputy CEO, CFO & VP Investor Relations
+46 (0)46-275 62 21, [email protected]
Abliva AB (publ)
Medicon Village, SE-223 81 Lund, Sweden
Tel: +46 (0)46 275 62 20 (switchboard)
[email protected], www.abliva.com
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