Therapy Areas: Infectious Diseases
Non–Cystic Fibrosis Bronchiectasis FDA Grants "Fast-Track" and "QIPD" to Zambon for Colistimethate Sodium Powder for Nebulizer Solution Delivered by the I-neb AAD System
12 December 2018 - - Colistimethate sodium powder for nebulizer solution, delivered by the I-neb AAD system obtained QIDP and "Fast Track" designation by the FDA for the indication "prevention of pulmonary exacerbations in adult patients with Non-Cystic Fibrosis Bronchiectasis colonized with Pseudomonas aeruginosa," Italy-based pharmaceutical company Zambon said.

Zambon's Open Research and Development (Open R and D) has developed a clinical program evaluating the efficacy and safety of colistimethate sodium powder for nebulizer solution delivered by the I-neb AAD system for patients suffering from NCFB, who are colonized with a Pseudomonas aeruginosa lung infection.

NCFB is a chronic disease that results in repeated serious pulmonary infections, which in turn can cause further inflammation and damage in the respiratory organs. Filing for registration is anticipated in the second half of 2021.

Colistimethate sodium is a polymixin antibiotic, and bactericidal against susceptible Gram-negative bacteria.

The drug will be provided for the clinical trials by Xellia Pharmaceuticals ApS., Zambon's long-standing partner, with which it shares the objective of bringing this formulation to patients with NCFB all over the world.

Colistimethate sodium is one of the antibiotics against Pseudomonas aeruginosa infections, and the I-Neb AAD system is an inhalation system designed to deliver nebulised medications into the lung. Antibiotics given by inhalation deliver high drug concentrations to the airways, minimizing systemic exposure and potential side effects.

Open R and D is conducting two Phase-III pivotal trials in the indication of prevention of pulmonary exacerbations in adult patients with Non-Cystic Fibrosis Bronchiectasis colonized with Pseudomonas aeruginosa.

PROMIS I is being carried out in Europe, Israel, Australia and New Zealand and PROMIS II in North and South America and in Europe.

By the end of the first half of 2019, it is expected that overall the two studies will enroll 840 patients.

CMS for the treatment of P aeruginosa infection has received Qualified Infectious Disease Product" and Fast Track designations.

Neb is a medical device manufactured by Philips and in partnership with Zambon is currently used to treat lung infections for patients suffering from Cystic Fibrosis.

Zambon is a multinational pharmaceutical and fine-chemical company that focuses on innovation and development with the aim to improve the quality of people's health and patients' lives.

Based on a valuable heritage but strongly focused on the future, its goal is to improve people's health through the development of innovative and quality medicines. Zambon products are commercialized in 86 countries.

The company has 20 subsidiaries in three different Continents Europe, America and Asia and owns manufacturing units in Italy, Switzerland, France, China and Brazil.

The company has a strong focus on the treatment of rare diseases and specialties, such as Parkinson's disease and Cystic Fibrosis, and it's well-established in 3 therapeutic areas: respiratory, pain and women's care. Zambon was established in 1906 in Italy and TODAY counts around 2,700 employees all over the world.

Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections.

Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R and D, manufacturing and commercial operations across Europe, Asia and North America and is investing significantly to expand its sales and manufacturing capabilities within the United States. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,500 people.
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