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EMA committee backs new administration methods for GSK asthma drug


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EMA committee backs new administration methods for GSK asthma drug

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended two new methods for administering GlaxoSmithKline PLC's asthma drug Nucala for EU approval.

The committee, also known as CHMP, issued a positive opinion on administering Nucala through a pre-filled pen and a pre-filled safety syringe — both options to be taken once every four weeks. Nucala is approved in the U.S., Europe and in over 20 other markets as an add-on maintenance treatment for patients with severe eosinophilic asthma, which is caused by high levels of white blood cells known as eosinophils.

The CHMP's positive opinion is based on two phase 3 studies evaluating the real-world use of Nucala administered through the new options in clinic and at home by patients with the disorder. A recommendation by the committee is one of the final steps prior to European Commission approval.

"If approved, the two new Nucala options will offer healthcare professionals the choice of prescribing at-home administration for appropriate patients," the U.K. drugmaker said in a news release.