Immunology company argenx SE (Euronext Brussels:ARGX) (Nasdaq:ARGX) reported on Tuesday that the US Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).
The PDUFA target action date is set for 21 June 2024.
CIDP is a rare and serious autoimmune disease of the peripheral nervous system, with symptoms including fatigue, muscle weakness and a loss of feeling in the arms and legs that can get worse over time or may come and go. Without treatment, one-third of people living with CIDP will need a wheelchair.
The application is backed by data from the ADHERE study, demonstrating a 61% lower relapse risk with VYVGART Hytrulo compared to placebo. In the open-label Stage A of the study, two-thirds (67%) of patients showed evidence of clinical improvement following treatment with VYVGART Hytrulo.
Pierre Fabre Pharmaceuticals reports FDA acceptance and Priority Review of Tabelecleucel BLA
Bavarian Nordic's chikungunya vaccine receives validation from EMA for accelerated review
Atara Biotherapeutics gains FDA Priority Review for tabelecleucel
Hyperfine secures FDA clearance for faster brain imaging software
Silo Pharma agrees Alzheimer's drug licence
Kyverna's KYV-101 granted FDA Regenerative Medicine Advanced Therapy designation
Camurus reports positive Phase 3 ACROINNOVA 2 results
Acurx Pharmaceuticals presents positive Ibezapolstat Phase 2 clinical trial results for CDI