Alcresta Therapeutics, Inc., a US-based commercial-stage company involved in developing and commercialising novel enzyme-based products, announced on Thursday that the US FDA has approved expanded use of RELiZORB to children ages two to less than five years. RELiZORB is a digestive enzyme cartridge designed to mimic the function of pancreatic lipase that was first FDA-cleared in 2015 for use in adult patients and was cleared in 2017 for use in children as young as five years old. It is the only enzyme product approved by the FDA for use with enteral feeding.
The approval for ages two to less than five years is based on a retrospective assessment of real-world data in subjects two to less than five years old who received enteral formula administered via RELiZORB under an enteral feeding regimen. No additional safety concerns were found with the product for use in this patient population.
Dan Orlando, Alcresta Therapeutics chief executive officer, said, 'This additional RELiZORB clearance represents access for approximately 25% of the cystic fibrosis enterally fed market and for enterally fed paediatric patients ages 2 to
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