The pharmaceutical company Aradigm Corporation received Fast Track status for its lead product candidate, Pulmaquin, from the U.S. Food and Drug Administration. The drug, which is being studied for treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients with chronic lung infections with Pseudomonas aeruginosa, is currently in phase 3 clinical trials.
The FDA’s Fast Track designation is aimed to facilitate the development of novel drugs designed for the treatment of serious or life-threatening conditions and that reveal the potential to address unmet medical needs, with the goal of getting important, new drugs to patients earlier. The status is given mainly based on the impact that the drug may have on factors such as survival, day-to-day functioning, or the likelihood that the condition, if untreated, will progress onto something more serious.
The status makes the drug eligible for more frequent meetings with FDA to discuss the its development plan and ensure the collection of appropriate data to support approval, as well as Rolling Review, which means that company won’t have to wait until every section of the application is completed before the entire application can be reviewed, but they can submit completed sections of its New Drug Application (NDA) for review by FDA. Also, if relevant, it may met the Eligibility for Priority Review. All of these benefits for the company also has a trickle-down effect for patients since, if the drug is approved, can make it to market sooner rather than later.
“We are very pleased to receive Fast Track designation for Pulmaquin to address an unmet medical need,” stated chief medical officer of Aradigm, Juergen Froehlich, MD. “In the context of the already granted Qualified Infectious Disease Product (QIDP) designation, it provides us with an outstanding opportunity to expeditiously develop Pulmaquin in non-CF BE patients with chronic lung infections with Pseudomonas aeruginosa.”
Ciprofloxacin is an antibiotic that used to treat acute lung infections. Pulmaquin is a dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. The drug is currently being studied in two ongoing phase III clinical trials, and the company believes that “the granting of Fast Track status is an important achievement that can facilitate accelerated review of an NDA submission based on the expected data from our current Phase 3 studies for Pulmaquin with the goal of bringing an important new treatment to these patients as quickly as possible,” the chief medical officer added.
The Fast Track designation for Pulmaquin follows the designation of Qualified Infectious Disease Product, which was granted earlier this year by the FDA and allowed the company to take advantage of certain drug development incentives that the FDA makes available for the creation of new antibiotics through their Generating Antibiotic Incentives Now Act.