Aradigm completes disastrous regulatory run as FDA slaps down Linhaliq application
Aradigm has completed the regulatory trifecta for disaster, stumbling from a bad FDA review to a negative panel vote and now a formal rejection for its inhaled antibiotic Linhaliq that will require a whole new Phase III program to overcome.
The writing for this asset has been on the wall since an outside panel of agency experts shook their heads over the mixed data gathered in two late-stage trials for the antibiotic, an inhaled formulation of ciprofloxacin which is designed to fight lung infections triggered by “abnormal dilatation of the bronchi and bronchioles.” Regulators had already dissed the data in their internal review.
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