Therapy Areas: Hereditary Disorders
Aradigm Submits Responses to EMA Day 120 Questions and Meeting with FDA
30 January 2019 - - US-based specialty pharmaceutical company Aradigm Corp. (OTCQB: ARDM) submitted responses to the European Medicines Agency Day 120 questions on 23 January 2019, the company said.

The due date for response to the questions was 25 January. The submission of the responses to the questions triggers the restart of the regulatory clock.

As part of the EMA regulatory review calendar for marketing authorization application submissions to the EMA for approval, Aradigm will expect a Day 180 List of Outstanding Issues in late March.

The clock will stop again until Aradigm responds to those issues, usually within thirty to sixty days.

One month later, Aradigm could expect an opinion by the Committee for Medicinal Products for Human Use to our request for approval or a presentation to the CHMP during a formal hearing, which will be followed by the CHMP opinion a month later.

As previously announced, a clinical US Food and Drug Administration meeting took place on 25 January 2019, with formal minutes expected within a month.

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of drugs for the prevention and treatment of severe respiratory diseases.

The company is currently in Phase 3 development of Apulmiq (an investigational proprietary formulation of ciprofloxacin for inhalation) for the treatment of patients with NCFBE and chronic lung infection with P. aeruginosa.

Aradigm's inhaled ciprofloxacin formulations are also product candidates for treatment of patients with cystic fibrosis and non-tuberculous mycobacteria, and for the prevention and treatment of high threat and bioterrorism infections, such as inhaled tularemia, pneumonic plague, melioidosis, Q fever and inhaled anthrax.

Non-Cystic Fibrosis Bronchiectasis 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 US and over 200,000 people in Europe. There is currently no drug approved for the treatment of this condition.


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