Eloxx Pharmaceuticals Announces Fast Track Designation for ELX-02 for the Treatment of Cystic Fibrosis Patients with Nonsense Mutations
“We are delighted to receive Fast Track Designation from the FDA for ELX-02 as the need for patients remains significant. The ability to have greater access to the FDA and their guidance on the regulatory pathway for ELX-02 can help provide the ability to work with the urgency needed on behalf of CF patients with nonsense mutations,” said
Fast Track Designation is granted to drugs being developed for the treatment of serious or life-threatening diseases or conditions where there is an unmet medical need. The purpose of the provision is to help facilitate development and expedite the review of drugs to treat serious or life-threatening conditions so that an approved product can reach the market expeditiously. Sponsors of drugs that receive Fast Track Designation have the opportunity for more frequent interactions with the FDA review team throughout the development program.
ELX-02 has previously been granted orphan drug designation by the FDA and orphan medicinal product designation by the
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This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of present and historical facts contained in this press release, including without limitation, statements regarding the expected timing of trials and results from clinical studies of our product candidate and the potential of our product candidate to treat nonsense mutations are forward-looking statements. Forward-looking statements can be identified by the words “aim,” “may,” “will,” “would,” “should,” “expect,” “explore,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “seeks,” or “continue” or the negative of these terms similar expressions, although not all forward-looking statements contain these words.
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Source: Eloxx Pharmaceuticals