FDA committee fails to recommend Linhaliq for chronic lung infection

Aradigm Corporation recently announced that the FDA’s Antimicrobial Drugs Advisory Committee did not recommend approval for Linhaliq to treat patients with noncystic fibrosis bronchiectasis who have chronic lung infections caused by Pseudomonas aeruginosa.

According to a press release, the FDA committee was asked if Aradigm “provided substantial evidence of the safety and efficacy of ciprofloxacin dispersion for inhalation in delaying the time to first exacerbation after starting treatment in noncystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa?”

Twelve committee members voted no, three voted yes and one abstained. The FDA is not bound by this decision, but it will be considered in making its final ruling.

"While we are disappointed with the outcome of the [Antimicrobial Drugs Advisory Committee] vote, we remain confident in the efficacy, safety and tolerability of Linhaliq in [non-cystic fibrosis bronchiectasis] patients,” Igor Gonda, PhD, president and CEO, Aradigm, said in a press release. “We will work closely with the FDA to address the issues discussed by the panel today as they complete their review of Linhaliq.”

According to the release, the company’s application was based on two simultaneous phase 3 placebo-controlled, double-blind, randomized, multinational trials. A Phase 2b study that was also included in the application also provided evidence of Linhaliq’s clinical benefits, Aradigm said.

The FDA has set a PDUFA action date of Jan. 26, 2018, to finish its review of Linhaliq. The medication was designated an Orphan Drug in June 2011, granted Qualified Infectious Disease Product status in June 2014 and received Fast Track designation in August of that same year.

There is currently no drug approved for the treatment of noncystic fibrosis bronchiectasis, according to the release, which also stated that the disease afflicts more than 150,000 persons in the United States.

Disclosure: Gonda works for Aradigm.

Aradigm Corporation recently announced that the FDA’s Antimicrobial Drugs Advisory Committee did not recommend approval for Linhaliq to treat patients with noncystic fibrosis bronchiectasis who have chronic lung infections caused by Pseudomonas aeruginosa.

According to a press release, the FDA committee was asked if Aradigm “provided substantial evidence of the safety and efficacy of ciprofloxacin dispersion for inhalation in delaying the time to first exacerbation after starting treatment in noncystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa?”

Twelve committee members voted no, three voted yes and one abstained. The FDA is not bound by this decision, but it will be considered in making its final ruling.

"While we are disappointed with the outcome of the [Antimicrobial Drugs Advisory Committee] vote, we remain confident in the efficacy, safety and tolerability of Linhaliq in [non-cystic fibrosis bronchiectasis] patients,” Igor Gonda, PhD, president and CEO, Aradigm, said in a press release. “We will work closely with the FDA to address the issues discussed by the panel today as they complete their review of Linhaliq.”

According to the release, the company’s application was based on two simultaneous phase 3 placebo-controlled, double-blind, randomized, multinational trials. A Phase 2b study that was also included in the application also provided evidence of Linhaliq’s clinical benefits, Aradigm said.

The FDA has set a PDUFA action date of Jan. 26, 2018, to finish its review of Linhaliq. The medication was designated an Orphan Drug in June 2011, granted Qualified Infectious Disease Product status in June 2014 and received Fast Track designation in August of that same year.

There is currently no drug approved for the treatment of noncystic fibrosis bronchiectasis, according to the release, which also stated that the disease afflicts more than 150,000 persons in the United States.

Disclosure: Gonda works for Aradigm.