EMA committee backs label change for GSK’s Relvar Ellipta asthma therapy

GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) said today that a European Medicines Agency committee has backed an updated label for its once-daily asthma therapy, Relvar Ellipta.

If granted marketing authorization by the European Commission, the combination drug treatment will be approved for use in patients whose asthma is already controlled on an inhaled corticosteroid and a long-acting beta-2-agonist.

In one non-inferiority lung function study, patients were able to switch from the twice-daily Seretide Accuhaler to the once-daily Relvar Ellipta without compromising lung function.

“There are many asthma patients in Europe who, despite being adequately controlled on a twice-daily ICS/LABA, are still experiencing symptoms or problems with their asthma,” Jonathan Sweeting, SVP & global head of GSK’s respiratory franchise, said in prepared remarks.”We are very excited about achieving this CHMP positive opinion which, if approved, provides an additional option for physicians, who can prescribe once-daily Relvar Ellipta for their asthma patients.”

“Asthma is a persistent condition; management guidelines recommend treatment be individualized until control has been achieved. Today’s positive opinion supports once-daily Relvar Ellipta as an important option for doctors and patients in effectively managing asthma,” Innoviva CEO Mike Aguiar added.

The companies reported that they expect a final decision regarding the product’s label update by the end of the first quarter of 2018.

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