Aradigm Announces FDA Acceptance of NDA for Linhaliq with Priority Review Status
HAYWARD, Calif.--(BUSINESS WIRE)--
Aradigm Corporation (NASDAQ: ARDM) (the "Company") today
announced that the U.S. Food and Drug Administration (FDA) has accepted
for filing with Priority Review its New Drug Application (NDA) for
Linhaliq™ for the treatment of non-cystic fibrosis bronchiectasis
(NCFBE) patients with chronic infections with Pseudomonas aeruginosa
The granting of Priority Review for the Linhaliq NDA accelerates the
timing of the FDA review of the application compared to a standard
review. The PDUFA (Prescription Drug User Fee Act) goal date for
completion of the FDA review of the Linhaliq NDA is January 26, 2018.
"We are pleased with the FDA's acceptance of our NDA filing with
Priority Review," said Dr. Igor Gonda, Chief Executive Officer, Aradigm
Corporation. "We look forward to working with the FDA during the review
process to support approval of Linhaliq and provide a much needed
treatment for NCFBE patients with chronic lung infection with P.
Aradigm received Orphan Drug Designation for liposomal ciprofloxacin for
inhalation for the management of bronchiectasis and for Linhaliq for the
management of bronchiectasis. Additionally, for Linhaliq, Aradigm was
granted Qualified Infectious Disease Product (QIDP) Designation for the
treatment of NCFBE patients with chronic lung infections with P.
aeruginosa followed by Fast Track Designation.
About Non-Cystic Fibrosis Bronchiectasis
Non-cystic fibrosis bronchiectasis (NCFBE) 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. NCFBE represents an unmet medical
need with high morbidity and mortality that affects more than 150,000
people in the U.S. and over 200,000 people in Europe. NCFBE patients who
have chronic infections with P. aeruginosa have a 6.5-fold
increase in hospitalization, three times higher mortality, and a worse
quality of life compared with those without P. aeruginosa
infections. There is currently no drug approved for the treatment of
Aradigm is an emerging specialty pharmaceutical company focused on the
development and commercialization of drugs for the prevention and
treatment of severe respiratory diseases. Aradigm has completed two
Phase 3 clinical trials with Linhaliq, an investigational proprietary
formulation of ciprofloxacin for inhalation, for the treatment of NCFBE
and submitted a New Drug Application to the FDA for this indication.
Aradigm's inhaled ciprofloxacin formulations, including Linhaliq, are
also product candidates for treatment of patients with cystic fibrosis
and non-tuberculous mycobacteria (NTM), and for the prevention and
treatment of high threat and bioterrorism infections, such as inhaled
tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax.
Except for the historical information contained herein, this news
release contains forward-looking statements that involve risk and
uncertainties, including the risk that Linhaliq may not receive
regulatory approval or be successfully commercialized, as well as the
other risks detailed from time to time in the Company's filings with the
Securities and Exchange Commission (SEC), including the Company's Annual
Report on Form 10-K for the year ended December 31, 2016 filed with the
SEC on March 30, 2017, and the Company's Quarterly Reports on Form 10-Q.
More information about Aradigm can be found at www.aradigm.com.
Aradigm and the Aradigm Logo are registered trademarks of Aradigm
Corporation. Linhaliq is a registered trademark of Grifols, S.A.
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Nancy Pecota, 510-265-8800
Source: Aradigm Corporation
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