European Medicines Agency Approves GSK / Theravance’s Relvar

GlaxoSmithKline (GSK) and Theravance’s inhaled lung drug, Relvar, has been approved by Europe’s regulatory body to treat both asthma and chronic obstructive pulmonary disease (COPD).

Relvar is a combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2 agonist (LABA) vilanterol, and is delivered through the Ellipta inhaler.  The drug has already been approved in the USA for COPD, where it is called Breo.

As part of their assessment, the European Medicines Agency (EMA) reviewed results of 10 clinical studies including 7,783 patients with COPD, and 16 clinical trials involving 9,326 patients with asthma.

The regulatory approval will result in a $15 million payment to GSK from Theravance, and the UK drugs major will receive an additional $15 million when the product is launched.

GlaxoSmithKline’s global respiratory franchise head, Darrell Baker, commented that the approval means that “healthcare professionals across Europe will have the option to prescribe an ICS/LABA that offers 24-hour efficacy from a once-daily dose, delivered in our new Ellipta inhaler.”


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