The Antimicrobial Drugs Advisory Committee (AMDAC) convened on January 11th, 2018 to discuss new drug application 210693, ciprofloxacin dispersion for inhalation (LINHALIQ), sponsored by Aradigm Corp.
The Antimicrobial Drugs Advisory Committee (AMDAC) convened on January 11th, 2018 to discuss new drug application 210693, ciprofloxacin dispersion for inhalation (LINHALIQ), sponsored by Aradigm Corp. The panel discussed the proposed indication of treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infection with Pseudomonas aeruginosa. Aradigm has since received a complete response letter (CRL) from the FDA (Jan. 29th, 2018), requesting additional clinical work.
LINHALIQ is an inhalation form of the antibiotic ciprofloxacin, a second-generation fluoroquinolone used to treat numerous types of bacterial infections. Aradigm stated that LINHALIQ helps improve pulmonary exacerbation experienced by patients with airway inflammation and recurrent respiratory infections caused by P. aeruginosa. Pulmonary exacerbation can be defined as an increase in cough/wheezing, changes in sputum characteristics, fatigue, and lethargy. The aim of LINHALIQ is to reduce the incidence of pulmonary exacerbation by acting as an effective treatment for recurrent P. aeruginosa lung infections in NCFBE patients.
Aradigm presented efficacy and safety data to the panel, which highlighted several important findings from their clinical work. Results indicated that the median time to the first pulmonary exacerbation was 221 days with LINHALIQ, versus 136 on placebo and LINHALIQ patients experienced almost a 40% reduction in pulmonary exacerbation frequency, versus placebo, over a 48-week period. Aradigm also concluded that there was no increase in respiratory adverse events and no observation of ciprofloxacin-resistant pathogen infections in patients treated with LINHALIQ during the clinical trials.
Following the sponsor and FDA presentations, the FDA directed a single voting question to the panel members. The question asked if Aradigm has provided substantial evidence of safety and efficacy of ciprofloxacin dispersion for inhalation in delaying the time to first exacerbation after starting treatment in NCFBE patients with chronic lung infections with P. aeruginosa. The panel members voted against the approval of LINHALIQ by a 12 (No) – 3 (Yes) vote.
During the post-vote discussion, panel members expressed concern over the duration of the clinical studies and the lack of clear explanation for conflicting findings between the two phase 3 trials. When asked to discuss suggestions for additional studies/analyses, panelists agreed that additional clinical work was needed to ensure the durability of both safety and efficacy findings beyond one year, such as P. aeruginosa resistance and reduced treatment effect. The FDA has since requested a third phase 3 trial be conducted, with a minimum study duration of two years, in their CRL to Aradigm. Additional CRL requests include further study of human factors related to packaging and supplemental product quality information.
ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact firstname.lastname@example.org
Do you have an upcoming Advisory Committee Meeting?
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us