The Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for the commercialization of Quinsair (240 mg) as a therapeutic for adult patients with cystic fibrosis with recurrent infections by Pseudomonas aeruginosa.
Cystic Fibrosis (CF) is an inherited disease that is characterized by defective mucus secretions from secretory glands, leading to the production of thick and sticky mucus. Mucus is important for keeping the lining of certain organs moist and preventing infections. In CF patients, the mucus produced accumulates, particularly in lungs and gastrointestinal organs, which frequently leads to the buildup of bacteria and culminates in repeated, serious lung infections. The thick mucus can also block ducts in the pancreas, for example, leading to impaired nutrient absorption. One of the most common organisms associated with chronic, progressive lung infections in CF is Pseudomonas aeruginosa, which leads to difficulty in breathing and often escalates to life-threatening pulmonary failure due to the bacteria’s ability to form biofilms.
Quinsair is commercialized by Aptalis Pharma SAS and has levofloxacin, a broad spectrum antibiotic from the fluoroquinolone antibacterial drug class, as an active substance. Specifically, the drug acts by inhibiting important bacteria enzymes for DNA replication, the bacterial DNA gyrase and topoisomerase IV enzymes. The drug improves the respiratory function of CF patients, as indicated by data from three clinical trials, Phase 2 (MPEX 204) and two Phase 3 studies (MPEX 207-209). The most commonly registered adverse side effects included cough/productive cough, dysgeusia (a distortion of the sense of taste) and fatigue/asthenia (weakness).
The CHMP is the European Medicines Agency (EMA) committee responsible for issuing the entire Agency’s’ resolutions concerning medicines for human use. The submitted material was was related to quality, safety and efficacy of Quinsair was evaluated by CHMP, which in turn decided to recommend Quinsair marketing as “Indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis (CF, see section 5.1).” The recommendations regarding Quinsair use will be detailed in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR). This report is published and accessible in all official European Union languages, once the European Commission grants Quinsair marketing authorization.