Rea­ta con­tin­ues to hit FDA road­blocks with its Friedre­ich’s atax­ia can­di­date, not­ing reg­u­la­tor 'con­cern­s'

Rea­ta Phar­ma­ceu­ti­cals is fac­ing an FDA wall on its small mol­e­cule can­di­date to treat Friedre­ich’s atax­ia, omavelox­olone. Ac­cord­ing to the com­pa­ny’s Q2 re­port, the FDA might still not be sold on the drug.

“[The FDA] con­tin­ues to have con­cerns re­gard­ing the strength of the ef­fi­ca­cy ev­i­dence. The FDA did not iden­ti­fy any sig­nif­i­cant clin­i­cal safe­ty is­sues. The FDA stat­ed that the safe­ty re­view is on­go­ing, and they are con­tin­u­ing to eval­u­ate the car­diac safe­ty of omavelox­olone in pa­tients with Friedre­ich’s atax­ia. They have not iden­ti­fied any oth­er ma­jor safe­ty con­cerns at this stage of their re­view,” the Q2 re­port said.

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