The Committee for Medicinal Products for Human Use (CHMP) recently announced a positive comment for the pharmaceutical compound Quinsair, a nebuliser solution administered in a 240 mg dose, based on the quality, safety and efficacy of the results submitted by Aptalis Pharma SAS. The results revealed a positive benefit-to-risk balance that prompted CHMP to recommend the granting of a marketing authorization. The Quinsair compound is prescribed for the treatment of chronic pulmonary infections by Pseudomonas aeruginosa in adult patients with cystic fibrosis.
Cystic fibrosis (CF) is a genetic disease that affects various organs and is characterized by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) protein, which results in regular infective pulmonary exacerbations with opportunistic pathogens, like Pseudomonas aeruginosa and Staphylococcus aureus (S. Aureus), which can cause inflammation, progressive destruction of the lung and ultimately death by respiratory failure. As a result, the discovery and development of novel drugs that can help CF patients combat bacterial lung infections such as Pseudomonas aeruginosa can be crucial in ensuring that quality of life and lifespan continue to improve for people with the disease.
In 2008 Quinsair, which is produced by Aptalis Pharma SAS, was nominated as an orphan pharmaceutical compound. Now, Aptalis Pharma SAS can ask for a re-evaluation of the CHMP opinion if the European Medicines Agency is notified of their written intention after 15 days of receiving the opinion. Quinsair includes the active substance levofloxacin, a fluoroquinolone antibacterial, J01MA12, which works by inhibiting the bacterial DNA gyrase and topoisomerase IV enzymes. The main positive effect of Quinsair is the ability to protect against the decline of respiratory function in cystic fibrosis patients evaluated in one Phase 2 (MPEX 204) and two Phase 3 clinical trials (MPEX 207-209). The most frequent advert effects are cough/productive cough, dysgeusia and fatigue/asthenia.
The drug safety, i.e. collection, detection, assessment, monitoring, and prevention of adverse effects, protocol for Quinsair will be established together with the marketing authorization. The adequate use of Quinsair will be explained in the summary of product characteristics (SmPC) published in the European public assessment report (EPAR) and available in all the official European Union languages when the European Commission has attributed the commercialization authorization.