Aradigm has withdrawn its application to the European Medicines Agency (EMA) requesting approval of Linhaliq for the treatment and prevention of flares in non-cystic fibrosis bronchiectasis patients with chronic lung infections linked to Pseudomonas aeruginosa bacteria.
The company’s decision followed a ruling by an EMA office that data supporting Linhaliq’s approval — in an application submitted in March 2018 — did not show a “positive benefit risk balance,” Aradigm said in its October withdrawal letter to the agency.
Linhaliq, known previously as Pulmaquin, is composed of the active substance ciprofloxacin, a potent antibiotic that prevents bacteria from multiplying to eventually cause their death.
Aradigm had presented data from two clinical studies that evaluated the safety and efficacy of a once-a-day inhaled formulation of Linhaliq in bronchiectasis patients with chronic P. aeruginosa lung infections.
In the ORBIT-3 (NCT01515007) and ORBIT-4 (NCT02104245) clinical trials, patients were randomized to either Linhaliq or a placebo for 48 weeks, followed by a 28-day open label extension study in which all were treated with Linhaliq.
Overall, results from the ORBIT studies showed that Linhaliq was safe and, compared with placebo, its use lengthened the time before a patient experienced a pulmonary exacerbation.
Linhaliq-treated patients in ORBIT-4 experienced a significant decrease in the frequency of pulmonary flares, and in the number of severe exacerbations and those that required antibiotic treatment.
But results in ORBIT-3, while showing benefits, did not reach statistical significance.
After the EMA reviewed data from both studies, it voiced some concerns and prepared questions for Aradigm. The agency’s opinion was that the two studies were not convincing regarding the efficacy of Linhaliq, and that the therapy’s benefits did not outweigh its risks.
EMA officials also questioned if the quality of the therapy was consistent.
Aradigm “had responded to the last round of questions, and the Agency was completing its assessment of the responses at the time of the withdrawal,” the EMA reported.
The company said there are no ongoing clinical trials or compassionate use programs involving Linhaliq.
The U.S. Food and Drug Administration (FDA) stood by its initial refusal to approve this oral antibiotic treatment, to be known as Apulmiq in the U.S., for the same patient group in February. The FDA cited discrepant results between the two ORBIT trials, and recommended an additional study.
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