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FDA Grants Fast Track Designation to Aradigm's Pulmaquin for Non-Cystic Fibrosis Bronchiectasis
A drug that receives Fast Track designation is eligible for some or all of the following:
More frequent meetings with
FDAto discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
- Eligibility for Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed
sections of its New Drug Application (NDA) for review by
FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA
According to the
The Fast Track designation for Pulmaquin follows the Qualified Infectious Disease Product (QIDP) designation that was granted earlier this year.
"We are very pleased to receive Fast Track designation for Pulmaquin to
address an unmet medical need. In the context of the already granted
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," said
Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used to treat acute lung infections and is often preferred because of its broad-spectrum antibacterial activity against various bacteria, such as Pseudomonas aeruginosa. Pulmaquin is a dual release formulation composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. It is being evaluated in two ongoing Phase 3 studies to determine its safety and effectiveness as a once-a-day inhaled formulation for the chronic treatment of non-CF BE.
Pulmaquin has been tested in preclinical safety studies (up to 3 months in rodents and 9 months in dogs).
Following Phase 2a development of the liposomal portion of Pulmaquin (Lipoquin®)and phase 1 development of Pulmaquin, the phase 2b study ORBIT-2 with Pulmaquin was a 24-week multicenter, randomized, double-blind, placebo-controlled trial in 42 adult non-CF BE subjects. This study demonstrated a significant reduction in P.aeruginosa sputum activity (p=0.002) and a decrease in time to first exacerbation in the per protocol population (p=0.046) and the mITT (p=0.057) populations in the Pulmaquin treated subjects compared to placebo. Overall, the incidence of all treatment emergent adverse events was similar between groups. The most frequently reported treatment related adverse events (reported by ≥ 3 patients in either treatment group) included product taste abnormal and nausea in the Pulmaquin group and wheezing in the placebo group. No serious adverse events were considered treatment related. There were no deaths reported during ORBIT-2.
The Phase 3 clinical program for Pulmaquin in non-CF BE consists of two worldwide, double-blind, placebo-controlled pivotal trials (ORBIT-3 and ORBIT-4) that are identical in design except for a pharmacokinetics sub-study to be conducted in one of the trials. Each trial is enrolling approximately 255 patients into a 48 week double-blind period consisting of 6 cycles of 28 days on treatment with Pulmaquin or placebo plus 28 days off treatment, followed by a 28 day open label extension in which all participants will receive Pulmaquin (total treatment duration approximately one year). The superiority of Pulmaquin vs. placebo during the double-blind period is being evaluated in terms of the time to first pulmonary exacerbation (primary endpoint), while key secondary endpoints include the reduction in the number of pulmonary exacerbations and improvements in the quality of life measures. Lung function is being monitored as a safety indicator.
About Non-Cystic Fibrosis Bronchiectasis
Non-CF BE is a severe, chronic and rare disease characterized by
abnormal dilatation of the bronchi and bronchioles, frequently
associated with chronic lung infections. It is often a consequence of a
vicious cycle of inflammation, recurrent lung infections, and bronchial
wall damage. Non-CF BE represents an unmet medical need with high
morbidity and mortality that affects more than 110,000 people in the
U.S. and over 200,000 people in
More information about
Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including those related to the ORBIT-3 and ORBIT-4
clinical trials, as well as the other risks detailed from time to time
in the Company's filings with the
Chief Financial Officer
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