Fen­nec looks for FDA ap­proval for hear­ing loss drug haunt­ed by man­u­fac­tur­ing prob­lems

Third time’s the charm. Maybe.

Fen­nec Phar­ma­ceu­ti­cals an­nounced this morn­ing that the FDA is re­view­ing its NDA for its on­ly can­di­date, an IV ther­a­py meant to pro­tect against hear­ing loss in chil­dren who re­ceive cis­platin chemother­a­py. This NDA marks the com­pa­ny’s third sub­mis­sion in three years, as it has been marred with man­u­fac­tur­ing is­sues for its drug.

In 2018, the North Car­oli­na-based biotech re­ceived fast track and break­through ther­a­py des­ig­na­tion for its ther­a­py, a sodi­um thio­sul­fate for­mu­la for chil­dren ages 1 month to un­der 18 years, known as Ped­mark. There are cur­rent­ly no avail­able treat­ments for cis­platin oto­tox­i­c­i­ty, or ear poi­son­ing, which is a ma­jor dose-lim­it­ing side ef­fect of chemother­a­py and is es­pe­cial­ly dam­ag­ing to chil­dren with head and neck can­cers.

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