Wired News – EMA Completed Validation of MAA for Aradigm’s Linhaliq in Non-Cystic Fibrosis Bronchiectasis
Stock Monitor: Bio-Path Holdings Post Earnings Reporting
LONDON, UK / ACCESSWIRE / April 09, 2018 / Active-Investors.com has just released a free research report on Aradigm Corp. (NASDAQ: ARDM). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ARDM as the Company's latest news hit the wire. On April 05, 2018, the Hayward-based pharmaceutical Company announced that the European Medicines Agency (EMA) has completed formal validation of the Marketing Authorisation Application (MAA) for Linhaliq for the treatment of non-cystic fibrosis bronchiectasis (NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa). Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Opinion from CHMP to be Released within Standard 210-Day Review Period
The EMA review of the MAA for Linhaliq will be according to standard timelines, with an opinion of the Committee for Medicinal Products for Human Use (CHMP) expected within 210 days. After the adoption of a CHMP opinion, a final decision regarding the MAA assessment is carried out by the European Commission on Day 277 of the procedure.
Submission of MAA to EMA for EU Marketing Approval of Linhaliq
The Company submitted its MAA to EMA for Linhaliq for the treatment of NCFBE patients with chronic lung infection with P. aeruginosa on March 09, 2018. The MAA was based on the positive Phase-3 pivotal clinical trial ARD-3150-1202 (ORBIT-4) and supporting evidence from Phase-3 study ARD-3150-1201 (ORBIT-3) and Phase-2b study ARD-3150-0902 (ORBIT-2), together with other supporting evidence from proprietary preclinical and clinical studies as well as referencing additional information about ciprofloxacin from publicly available sources.
Aradigm Submitted NDA to FDA for US Marketing Approval of Linhaliq in NCFBE
In July 2017, the Company submitted its New Drug Application (NDA) to the US FDA for Linhaliq for the treatment of NCFBE patients with chronic P. aeruginosa. In January 2018, the FDA determined that it could not approve the NDA in its present form and provided specific reasons for this action along with recommendations needed for resubmission; the areas of concern include clinical data, human factors validation study, and product quality.
About Linhaliq
Linhaliq, formerly known as Pulmaquin®, is composed of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Ciprofloxacin, available in oral and intravenous formulations, is a widely prescribed antibiotic. It is used often to treat acute lung infections because of its broad-spectrum antibacterial activity against various bacteria, such as P. aeruginosa. There are currently no treatments approved for NCFBE patients to prevent and reduce the number of pulmonary exacerbations (PEs).
About Non-Cystic Fibrosis Bronchiectasis
NCFBE is a severe, chronic, and rare disease characterized by irreversibly and 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. There is currently no drug approved for the treatment of this condition. 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 to those without P. aeruginosa infections.
About Aradigm Corp.
Founded in 1991 and headquartered in Hayward, California, Aradigm is an emerging specialty pharmaceutical company developing and commercializing a portfolio of drugs delivered by inhalation for the treatment of severe respiratory disease.
Stock Performance Snapshot
April 06, 2018 - At Friday's closing bell, Aradigm's stock dropped 5.38%, ending the trading session at $1.23.
Volume traded for the day: 61.40 thousand shares.
Stock performance in the last month – up 10.81%
After last Friday's close, Aradigm's market cap was at $19.86 million.
The stock is part of the Healthcare sector, categorized under the Drug Delivery industry.
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