GSK gets positive CHMP opinion for labelling update
Source - SMW
GlaxoSmithKline has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion for a labelling update to Relvar Ellipta in patients with asthma.
Relvar Ellipta is a once-daily dual combination treatment comprising fluticasone furoate, an inhaled corticosteroid and vilanterol, a long-acting β2-agonist, in a single inhaler, the Ellipta.
GSK senior vice-president and global head of respiratory franchise Jonathan Sweeting said: '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.
'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.'
A positive CHMP opinion is one of the final steps before marketing authorisation is updated by the European Commission.
GSK said a final decision was anticipated towards the end of the first quarter.
At 9:12am: (LON:GSK) GlaxoSmithKline PLC share price was +10.2p at 1345.2p