FDA recently approved reslizumab (Cinqair, Teva Pharmaceuticals), an injectable used with other asthma medicines for the maintenance treatment of severe asthma. Here are the top 5 facts to know about Cinqair.
FDA recently approved reslizumab (Cinqair, Teva Pharmaceuticals), an injectable used with other asthma medicines for the maintenance treatment of severe asthma. Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.
“Despite ongoing treatment with today’s standard of care, many patients with severe asthma remain inadequately controlled, the implications of which can lead to increased exacerbations and hospitalization,” said Mario Castro, professor with the Washington University School of Medicine, Division of Pulmonary and Critical Care Medicine and lead investigator. “The approval of Cinqair marks an important advancement in the treatment paradigm for asthma as the therapy has demonstrated significant improvement in multiple measures of asthma control.”
Here are the top 5 facts to know about Cinqair:
1. The treatment is expected to become commercially available to patients by prescription during the second quarter of 2016.
2. This is the first approval of Cinqair in the world. Reslizumab has been submitted to and is currently under review by European Medicines Agency (EMA) and Health Canada.
3. Cinqair is administered by intravenous (IV) infusion at a weight-based dose of 3 mg/kg once every 4 weeks.
4. The safety and efficacy of Cinqair were established in four double-blind, randomized, placeboâcontrolled trials in patients with severe asthma on currently available therapies. Cinqair or a placebo was administered to patients every four weeks as an add-on asthma treatment. Three phase 3 studies found that Cinqair was associated with a reduction in asthma exacerbations of up to 59%, as well as significant improvement in lung function, symptoms, and asthma-related quality of life.
5. The most common adverse reaction (incidence greater than or equal to 2%) in patients treated with Cinqair was oropharyngeal pain. Other side effects included anaphylaxis and cancer.