Rocket Pharma Receives FDA's Complete Response Letter For Kresladi
(RTTNews) - Rocket Pharmaceuticals, Inc. (RCKT) announced on Friday that the FDA has issued a Complete Response Letter regarding Rocket's Biologics License Application for Kresladi, requesting limited additional Chemistry Manufacturing and Controls or CMC information to complete its review.
The company stated that it has communicated with senior FDA officials from the Center for Biologics Evaluation and Research to clarify the exact CMC details needed to speed up the approval of Kresladi.
Rocket's global Phase 1/2 study of Kresladi has achieved all primary and secondary endpoints. Results showed 100 percent overall survival at 12 months post-infusion, significant reductions in infection rates compared to pre-treatment levels, and the absence of any serious adverse events related to the treatment.
Kresladi is a lentiviral vector-based gene therapy designed to address severe leukocyte adhesion deficiency-I, a rare pediatric disease with autosomal recessive inheritance.
