If the agency recommends its approval, Linhaliq’s Marketing Authorization Application will go to the European Commission, which will make the final decision. The commission is expected to issue a ruling about nine months after the regulatory review starts — which would mean early 2019.
The medicines agency’s decision to review the application “is a milestone event for Aradigm. We look forward to working with EMA [the agency] to gain approval for Linhaliq,” Aradigm said in a press release. “If approved by the European commission, Linhaliq will provide a much-needed treatment for patients with NCFBE with chronic lung infections with P. aeruginosa.”
Linhaliq, formerly known as Pulmaquin, is an inhaled version of the antibiotic ciprofloxacin. Doctors often prescribe ciprofloxacin for acute lung infections. It can combat a number of bacteria, including P. aeruginosa.
The marketing application was based on the results of the Phase 3 ORBIT-3 (NCT01515007) and ORBIT-4 (NCT02104245) clinical trials. The two had the same design. The initial phase, in which participants did not know whether they were getting Linhaliq or a placebo, covered 48 weeks. Then there was an additional four weeks of treatment and a 30-day follow-up.
Both trials showed that Linhaliq increased the time it took for a patient to have a lung flare-up, although the results were statistically significant only in the ORBIT-4 trial.
As for treating an infection, the trials showed that Linhaliq led to a marked decrease in P. aeruginosa by the end of the first treatment cycle.
Aradigm changed the statistical analysis method it used in the trials after the U.S. Food and Drug Administration rejected its New Drug Application for Linhaliq.
The FDA asked Aradigm for an independent verification of the trial findings and analysis. It also asked for another Phase 3 trial that could show whether Linhaliq was effective over two or more years.
In addition, the agency expressed concern about the treatment’s safety and manufacturing process. It asked for another study on whether the product packaging and label instructions were clear, and if it could be used safely and effectively.
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