4D Molecular Therapeutics announced that the FDA granted Rare Pediatric Disease Designation (RPDD) for the Company’s product candidate aerosolized 4D-710 for treatment of cystic fibrosis (CF) lung disease. 4D-710 is being evaluated in the Phase 1/2 AEROW clinical trial in people with CF who are not eligible for, or cannot tolerate any of, the currently approved CFTR modulators.
RPDD may be granted to investigational drugs and biologics designed to address serious or life-threatening diseases primarily affecting individuals 18 years of age and under, and meeting the definition of “rare disease or condition” (affects less than 200,000 individuals in the U.S.). If the drug or biologic is approved for marketing, 4DMT may qualify for a priority review voucher that may be transferred or sold t o another sponsor.
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