TOP NEWS: GlaxoSmithKline Gets EU Approval For Wider Relvar Drug Use

8th Mar 2018 08:10

LONDON (Alliance News) - GlaxoSmithKline PLC said Thursday its asthma and chronic obstructive pulmonary disease drug Relvar Ellipta has received a "positive" EU approval with regards its use and marketing.

The EU Commission approved a marketing authorisation label update for Glaxo's once-daily Relvar Ellipta drug. This followed the regulatory submission of data from a study.

The approval followed Glaxo receiving a "positive opinion" regarding its label update from the Committee for Medicinal Products for Human Use of the European Medical Agency in late January.

The recommended label update will allow the use of Relvar Ellipta - an inhaled corticosteroid and long-acting Beta2-agonist - for patients whose asthma is already adequately controlled on both an inhaled corticosteroid and long-acting Beta2-agonist, Glaxo explained.

The label will be updated in the European Union.

"Patients with asthma can continue to experience symptoms despite being adequately controlled and these symptoms can impact their lives. This label update gives doctors the option of switching appropriate patients from their current ICS/LABA to once-daily Relvar Ellipta", Glaxo Global Head of Respiratory Franchise Jonathan Sweeting said.

Shares in Glaxo were 0.1% higher at 1,322.20 pence in early trading Thursday.

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