What is Cinqaero - Reslizumab and what is it used for?
Cinqaero is a medicine for the treatment of asthma used for a particular type of asthma in adults, known as eosinophilic asthma. It is used as an adjunctive treatment in adult patients with severe asthma not adequately controlled by corticosteroids at high doses administered by inhalation and associated with another medicine used for the prevention of asthma. The drug contains the active substance reslizumab.
How is Cinqaero - Reslizumab used?
Cinqaero can only be obtained with a prescription and must be prescribed by physicians experienced in the treatment of eosinophilic asthma. It is available as a concentrate for the preparation of a solution for infusion (drip) into a vein. The recommended dose is 3 mg for each kg of body weight. The infusion should be administered once every four weeks until the patient is deemed to benefit and the doctors should evaluate at least once a year whether to continue the therapy. For more information, see the package leaflet.
How does Cinqaero - Reslizumab work?
The eosinophilic asthma symptomatology is associated with an excessive presence of eosinophils, a type of white blood cell, in the blood and in pulmonary mucus. The active substance in Cinqaero, reslizumab, is a monoclonal antibody designed to bind to a substance called interleukin-5, which stimulates the growth and activity of eosinophils. By binding to interleukin-5 and blocking its activity, Cinquaero reduces the number of eosinophils in the blood and lungs. This helps reduce inflammation, resulting in reduced asthma attacks and improved symptoms.
What benefit has Cinqaero - Reslizumab shown during the studies?
Cinqaero's benefits have been demonstrated in two main studies involving 953 patients with eosinophilic asthma not adequately controlled by inhaled corticosteroids and other asthma medicines used for disease prevention. Cinqaero was compared with placebo (a dummy infusion), both given every 4 weeks for a year. The main measure of effectiveness was based on the number of asthma attacks (exacerbations) during treatment. Asthma attacks were observed in 32% of patients (151 out of 477) treated with Cinqaero compared to 50% (237 of 476) of those treated with placebo. Evidence of improvement in lung function and asthma symptoms as well as a decrease in the number of eosinophils in the blood in patients treated with Cinqaero also emerged. Other supporting data indicated that the benefit was maintained for up to two years.
What are the risks associated with Cinqaero - Reslizumab?
The most common side effect of Cinqaero (which may affect about 2 in 100 people) is an increase in the levels of the enzyme creatine phosphokinase in the blood (an indication of possible muscle damage). Anaphylactic reactions (severe allergy) may affect less than 1 in 100 people.
For the full list of restrictions and side effects reported with Cinqaero, see the package leaflet.
Why has Cinqaero - Reslizumab been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cinqaero's benefits are greater than its risks and recommended that it be approved for use in the EU. The reduction in asthma attacks and the improvement in lung function observed with Cinqaero have been considered clinically relevant, particularly for patients who cannot be adequately controlled with high doses of inhaled corticosteroids and another medicine used for the prevention of 'asthma. Overall the medicine was well tolerated and measures were put in place to control and manage the risks.
What measures are being taken to ensure the safe and effective use of Cinqaero - Reslizumab?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cinqaero have been included in the summary of product characteristics and the package leaflet.
More information on Cinqaero - Reslizumab
For the full EPAR version of Cinqaero, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Cinqaero therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
