Regulatory, Setbacks

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.

Igor Gonda

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.

Its shares $ARDM took another nose dive this morning, tumbling 39% to $1.36 — after sliding steadily from $6.70 at the beginning of last December.

Getting over this hurdle will neither be cheap or quick.

The Hayward, CA-based company says the FDA wants a new Phase III trial that can provide evidence of two years or more of durability in preventing “the co-primary endpoints of frequency and severity of exacerbations.” Regulators are also looking for independent verification of its current Phase III data, a human factors study to back up the label and an in vitro report on the drug release method development.

Aradigm CEO Igor Gonda says the company plans to meet with the FDA on resubmission, while pursuing an approval in the EU.

New FDA commissioner Scott Gottlieb had pledged to start opening up on CRLs when he was confirmed for the top job at the FDA. But in the meantime he’s decided to renege on that promise, looking for a compromise on transparency through a new trial program that rests on voluntary submission of some info. Companies are still free to present CRLs any way they like, despite criticism from regulators that not all biopharma companies are entirely upfront about why their drugs are rejected.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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