Krystal Clears Path To Market For Topical Gene Therapy Vyjuvek
The company estimates there are about 9,000 reimbursable patients with dystrophic epidermolysis bullosa worldwide and anticipates a third-quarter launch following FDA approval.
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The US FDA could approve as many new gene therapies in 2023 as it has in the previous five years. Development in the field has rapidly accelerated, but still faces hurdles.
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Chiesi-owned Amryt and Krystal Biotech have approved treatments for epidermolysis bullosa but Paradigm CEO Robert Ryan tells Scrip that SD-101, a topical cream he helped develop over 20 years ago, has the potential to be offer a far more extensive and efficacious solution for many more sufferers.