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news.The US Food and Drug Administration (FDA) has granted fast-track status to Enobia Pharma’s enzyme replacement therapy ENB-0040. The therapy is being developed for the treatment of hypophosphatasia (HPP), a rare and potentially genetic life-threatening bone disease.
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Enzyme replacement therapy for the treatment of HPP is the company’s lead program.
The FDA has granted fast track designation in part because HPP is an untreated, serious and potentially life-threatening disorder, Enobia said.
The company will now have access to current discussions and communications with the regulator to facilitate the ENB-0040 development and review process.
Hal Landy, Chief Medical Officer and VP of Medical Affairs, Enobia, said: “We’re pleased that the FDA has recognized that ENB-0040 may provide a much needed treatment for patients with this devastating, often fatal inherited bone disease.”