Specialty pharmaceutical company Aradigm has received a negative response from the FDA regarding its New Drug Application (NDA) for the company’s inhaled antibiotic, Linhaliq. The Complete Response Letter (CRL) outlines measures that must be taken by the California-based Aradigm before resubmitting their drug for approval.
Linhaliq is an inhaled version of the antibiotic ciprofloxacin, which is used to treat patients with non-cystic fibrosis bronchiectasis (NCFBE) who are also suffering from chronic lung infections with Pseudomonas aeruginosa. NCFBE is a rare disease in which the abnormal dilation of the air passages in the lungs – known as bronchi and bronchioles – leads to frequent lung infections.
According to Aradigm, the FDA expressed concerns regarding clinical data, product quality and Human Factors Study results. In the CRL, the regulator recommended Aradigm get an independent third party to review the results of their Phase III studies to confirm the company’s own findings.
In addition, the FDA suggests Aradigm should conduct an additional Phase III trial to determine whether Linhaliq has a significant effect on the frequency and severity of exacerbations. The regulator recommends this efficacy study be conducted over a period of at least two years.
Another Human Factors Study will also need to be completed to make sure the packaging and instructions for using the inhalable Linhaliq are effective. Additional product quality information was also requested by the regulator.
“We remain confident in the efficacy, safety and quality of Linhaliq and will request a meeting with FDA to discuss the topics covered in the CRL with the view to developing plans to move towards resubmission of the Linhaliq NDA as soon as possible,” said Dr. Igor Gonda, president and chief executive officer at Aradigm. “We are committed to continue working on the approval of Linhaliq for NCFBE patients who have very severe disease with high morbidity and mortality and no available treatment options.”
Anadigm’s original NDA was based on the mixed results of one Phase IIb study and two placebo controlled Phase III studies. This data was reviewed by an independent FDA advisory committee in early January, who found that the data was unconvincing and voted against regulatory approval.
In addition to focusing on getting the FDA-requested data for their next NDA, the company plans on submitting Linhaliq for EMA approval in the near future.
Over 150,000 people in the US have been diagnosed with NCFBE, and there are no treatment options available for this condition. Chronic P. aeruginosa have a negative effect on NCFBE patient outcomes, making them more likely to hospitalized and three times more likely to die as a result of the infection.