FDA Approves Nucala for Severe Asthma
The Food and Drug Administration (FDA) has approved Nucala (mepolizumab; GlaxoSmithKline) for injection as add-on maintenance treatment of patients with severe asthma aged ≥12 years. It is indicated for use in patients who have a history of severe exacerbations despite receiving their current asthma medicines.
The safety and efficacy of Nucala were established in three double-blind, randomized, placebo-controlled trials in patients with severe asthma on currently available medicines. Study patients were given either Nucala or placebo every 4 weeks as an add-on asthma treatment. Treatment with Nucala resulted in fewer exacerbations requiring hospitalization and/or emergency department visits, and a longer time to the first exacerbations when compared to placebo.
Also, patients treated with Nucala saw greater reductions in their daily maintenance oral corticosteroid dose, while maintaining asthma control vs. patients treated with placebo. A significant improvement in lung function, however, was not seen with Nucala, as measured by the volume of air exhaled by patients in one second.
Nucala, a humanized interleukin-5 antagonist monoclonal antibody, is produced by recombinant DNA technology in Chinese hamster ovary cells. It reduces severe asthma attacks by decreasing the production and survival of eosinophils.
Nucala will be available as 100mg preservative-free, lyophilized powder in single-dose vials. It is administered once every four weeks by subcutaneous injection by a healthcare professional into the upper arm, thigh, or abdomen. It is anticipated to launch before the end of 2015.
For more information call (888) 825-5849 or visit Nucala.com.