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LONDON (Alliance News) - GlaxoSmithKline PLC on Thursday said it has been authorised to market its asthma treating drug mepolizumab after the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending marketing authorisation of the drug.
It follows on from the FTSE 100 pharmaceutical giant submitting an marketing authorisation application for mepolizumab back in November 2014. The decision by the committee is a formal recommendation to grant marketing authorisation for mepolizumab.
Mepolizumab will be commercialised under the brand name Nucala, as an add-on treatment for severe refractory eosinophilic asthma in adult patients.
The decision by the committee was based on the results from the clinical study programme, which identified the patients that may be suitable for treatment with mepolizumab.
Severe refractory eosinophilic asthma patients who participated in the Phase III trials were evaluated by eosinophil level and either a history of recurrent exacerbations or dependency on systemic corticosteroids. All patients were on high-dose inhaled corticosteroids plus another maintenance treatment.
The Phase III clinical development programme for mepolizumab investigated the efficacy and safety of mepolizumab in 915 patients with severe asthma who received mepolizumab in addition to standard of care.
"For these difficult-to-treat patients there are very limited treatment options. 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," said Dave Allen, head of the respiratory therapy area unit.
"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," he added.
GlaxoSmithKline shares were down 0.7% 1,265.50 pence per share on Thursday afternoon
By Joshua Warner; joshuawarner@alliancenews.com; @JoshAlliance
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