GlaxoSmithKline plc GSK announced that its respiratory drug, Nucala (mepolizumab), gained approval in the EU as an add-on treatment of adults suffering from severe refractory eosinophilic asthma. This makes Nucala the first and only anti-interleukin-5 (IL-5) monoclonal antibody to be approved in the EU for the treatment of patients with severe refractory eosinophilic asthma.
EU approval was largely expected as the Committee for Medicinal Products for Human Use had issued a favorable opinion this September. The drug will be available for subcutaneous administration every four weeks in addition to the patient’s normal respiratory medication.
In a separate press release, Glaxo announced that Nucala has been launched in the U.S. We remind investors that Nucala was approved in the U.S. last month as an add-on maintenance treatment of patients aged 12 years and above with severe asthma, and with an eosinophilic phenotype.
The approval of Nucala comes as a huge boost for Glaxo considering that the company’s respiratory franchise is under significant pressure with Advair facing increasing competitive and pricing pressure. Glaxo is currently looking to make up for the loss of revenues in the respiratory segment with the launch of new products like Relvar/Breo Ellipta, Anoro Ellipta and others.
We note that several companies including Teva Pharmaceutical Industries Limited TEVA and AstraZeneca plc AZN are looking to bring their anti IL-5 antibodies to the market for the treatment of severe asthma and chronic obstructive pulmonary disease.
Glaxo is a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are AstraZeneca and Achillion Pharmaceuticals, Inc. ACHN. Both carry a Zacks Rank #1 (Strong Buy).
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