FDA OKs Teva’s mAb for Asthma
The US Food and Drug Administration has approved Teva Pharmaceutical Industries Ltd.’s Cinqair (reslizumab) injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.
Cinqair is administered by intravenous (IV) infusion at a weight-based dose of 3 mg/kg once every four weeks. The treatment is expected to become commercially available to patients, by prescription, during the second quarter of 2016.
Reslizumab has been submitted to and is currently under review by European Medicines Agency and Health Canada.
Source: Teva Pharmaceutical