Rea­ta’s ‘reg­u­la­to­ry con­cerns’ turn in­to three-month de­lay on FDA de­ci­sion for Friedre­ich’s atax­ia drug

In its Q2 re­port Mon­day, Rea­ta Phar­ma­ceu­ti­cals said that the FDA con­tin­ues to have con­cerns about its Friedre­ich’s atax­ia drug.

On Tues­day, those con­cerns man­i­fest­ed in a three-month de­lay on an FDA ap­proval de­ci­sion. Rea­ta’s new FDA de­ci­sion dead­line for its Friedre­ich’s atax­ia drug, omavelox­olone, is the end of Feb­ru­ary 2023, it an­nounced this morn­ing.

In the Q2 re­port, Rea­ta not­ed that the FDA was con­cerned about the ef­fi­ca­cy of omavelox­olone. The Plano, TX-based biotech said that in re­sponse to those con­cerns, it sub­mit­ted ad­di­tion­al da­ta from its clin­i­cal tri­al. But in or­der to re­view that new da­ta, the FDA needs more time, hence the three-month de­lay, Rea­ta said Tues­day morn­ing.

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