Aradigm discussed data from Phase 3 trials assessing the company’s inhaled form of ciprofloxacin, called Linhaliq (formerly known as Pulmaquin), with the U.S. Food and Drug Administration (FDA) to advance the drug’s development and obtain marketing authorization and approval.
Linhaliq is based on an inhalable formulation of the antibiotic ciprofloxacin, and is being developed as a therapy for non-cystic fibrosis (non-CF) bronchiectasis.
Non-CF bronchiectasis is a rare lung disease affecting more than 150,000 people in the U.S. and even more in Europe. There is currently no approved drug for the treatment of the condition.
Pre-new drug application (NDA) meetings regarding Linhaliq were held between Aradigm and the FDA in December last year and more recently in March. NDAs are required in the U.S. for the sale and marketing of pharmaceuticals; they confirm the safety and effectiveness of the product.
The original trade name Pulmaquin suggested by Aradigm was rejected by the FDA because it sounds too much like other drugs for the treatment of lung diseases. The brand name Linhaliq has received conditional approval by the FDA.
Linhaliq contains encapsulated and unencapsulated ciprofloxacin in a formulation designed for dual release in a once-daily, inhaled dose. Ciprofloxacin is a widely prescribed antibiotic, often used to treat acute lung infections because it acts against different species of bacteria, including Pseudomonas aeruginosa.
“We had a meeting with FDA on March 17, 2017, and we continue to work with them, as well as with the European Medicines Authority, towards submission of marketing authorizations and approval of our inhaled antibiotic for the treatment of non-cystic fibrosis bronchiectasis patients whose life is severely impaired by chronic lung infections with Pseudomonas aeruginosa,” Juergen Froehlich, Aradigm’s chief medical officer, said in a news release.
“In addition, we are pleased to publicly announce the new tradename for our product candidate – Linhaliq,” he added.
Similar formulations from Aradigm are treatment candidates for cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections.
In both Phase 3 studies evaluating Linhaliq, ORBIT-3 (NCT01515007) and ORBIT-4 (NCT02104245), patients with non-CF bronchiectasis treated with the drug showed a higher median time to first pulmonary exacerbation than those in the placebo group, and a decrease in the number of pulmonary exacerbations over the study period compared to the placebo group.