European Medicines Agency issues positive opinion of Mepolizumab
“For these difficult-to-treat patients, there are very limited treatment options,” Respiratory Therapy Area Unit R&D Head Dave Allen said. “Many struggle to control their asthma even when taking high doses of inhaled therapies and are often reliant on daily oral corticosteroids, which can cause serious long-term side effects. This positive opinion brings us a step closer to adding a targeted biologic therapy, specifically developed for patients with severe eosinophilic asthma, to our respiratory portfolio.”
Mepolizumab is not approved for use anywhere else in the world, although regulatory applications are in the works in a number of different companies, including the U.S. and Japan.
According to GlaxoSmithKline, as many as 242 million people live with asthma in the world. Many of the existing therapies can provide adequate control over symptons, but five to 10 percent of those patients are estimated to have severe asthma. Severe asthma is defined as an “asthma that requires treatment with high dose inhaled corticosteroids (ICS) plus a second controller (and/or systemic corticosteroids) to prevent it from becoming ‘uncontrolled’ or which remains ‘uncontrolled’ despite this therapy.”
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