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FDA panel rejects Aradigm/Grifols’ inhaled antibiotic

Further evidence is required to warrant approval according to the US regulator

FDA

Aradigm has been unable to convince an FDA advisory committee that that its inhaled version of ciprofloxacin should be approved for chronic infections in patients with a serious lung disease.

The panel concluded that Aradigm had not provided sufficient evidence to warrant recommending the FDA license Linhaliq as a treatment for non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung Pseudomonas aeruginosa infections.

Aradigm shares had already been on the slide ahead of the advisory committee meeting on comments made in the FDA reviewer’s briefing document, and dropped another 46% in after-hours trading to $3.42, having been above the $6.50 mark at the beginning of the year.

In the briefing document, the FDA reviewer concluded that one of Aradigm’s pivotal studies for the inhaled antibiotic - ORBIT-3 - failed to show a treatment effect for the drug while another (ORBIT-4) was positive, and said it was unclear whether the latter trial’s clinical endpoint (time to first exacerbation) was clinically meaningful.

Linhaliq is a once-daily formulation of the widely-used antibiotic, based on liposome encapsulation that is designed to provide a sustained delivery of the drug into lung tissue whilst minimising systemic exposure.

Aradigm CEO Igor Gonda said the company would work closely with the FDA to address the issues discussed by the panel as the regulator completes its review of Linhaliq, which is due to complete on January 26.

“While we are disappointed with the outcome of the … vote, we remain confident in the efficacy, safety and tolerability of Linhaliq in NCFBE patients,” he said, adding that at the moment patients with NCFBE have no treatment options.

NCFBE is a severe, chronic and rare disease characterised by abnormal dilatation of the main airways (bronchi and bronchioles) in the lungs, and is frequently associated with chronic lung infections. It is estimated to affect around 150,000 people in the US and 200,000 people in Europe.

The setback is also a blow to Spanish drugmaker Grifols, which bought into the phase III programme for Linhaliq in 2013 ago and funded the late-stage trials. It paid Aradigm a $5m milestone last September after the rug was filed in the US.

Article by
Phil Taylor

12th January 2018

From: Regulatory

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