FDA approves Cinqair for severe asthma treatmentAmy Walsh (Author) Published Date : Mar 24, 2016 19:27 IST
FDA has cleared reslizumab (Cinqair Teva) for use with other asthma medicines for the maintenance treatment of severe asthma in adults. The drug is indicated for patients with a history of severe asthma attacks despite using their current asthma drugs. Reslizumab is administered, via I.V. infusion, once every 4 weeks. The drug is administered by a health care professional in a clinical setting to manage the risk of anaphylaxis.
Clinical trials demonstrated that individuals who received reslizumab had fewer asthma attacks and a longer time to the first attack. Patients treated with reslizumab also had significant improvement in lung function.
FDA notes that reslizumab can cause serious adverse events, including hypersensitivity reactions, which can be life-threatening. The most frequently reported adverse events in clinical trials were anaphylaxis, cancer, and muscle pain.
Under the said approval, patients 18 years old and above may take the drug together with other asthma medicines for the maintenance and treatment of severe asthma.
Such move allows asthmatic patients who have a history of severe attacks to have another supportive drug despite taking other existing therapies.
Asthma is a chronic disease that causes inflammation in the airways of the lungs. During an asthma attack, airways become narrow making it hard to breathe. Severe asthma attacks can lead to asthma-related hospitalizations because these attacks can be serious and even life-threatening. According to the Centers for Disease Control and Prevention, as of 2013, more than 22 million people in the U.S. have asthma, and there are more than 400,000 asthma-related hospitalizations each year.
Health care providers and their patients with severe asthma now have another treatment option to consider when the disease is not well controlled by their current asthma therapies, said Badrul Chowdhury, M.D., Ph.D., director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA s Center for Drug Evaluation and Research.
Cinqair can cause serious side effects including allergic (hypersensitivity) reactions. These reactions can be life-threatening. The most common side effects in clinical trials for Cinqair included anaphylaxis, cancer, and muscle pain.
FDA approves Cinqair for severe asthma treatment