GlaxoSmithKline (GSK) has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) on dosing of Seretide (salmeterol/fluticasone propionate) forinitial maintenance therapy in patients with moderate persistent asthma for whom rapid control of asthma is essential.
Dose recommendations have been agreed between GSK and the CHMP, which are designed to help clinicians to prescribe Seretide appropriately as an initial maintenance therapy. This is the first step towards obtaining updated national marketing authorisations. Once this amendment has been adopted by the European Commission, clinicians will have guidance in terms of the patient population which will benefit most from Seretide therapy at the most appropriate starting dose, claims a company release.
Kate Knobil, VP Respiratory Clinical Development, GSK said: "We are delighted that the CHMP have issued a positive opinion accepting proposed wording for the Seretide label to include initial maintenance therapy use in appropriate asthma patients. This means that if the CHMP opinion is approved Seretide will be the only ICS/LABA combination with guidance on use as an initial maintenance therapy."
The opinion provided by the CHMP is in line with current GINA guidelines, which state that therapy should be initiated on the basis of the severity of a patient's asthma. For patients presenting with moderate persistent asthma, the daily controller medications recommended are inhaled corticosteroids (ICS) plus long acting beta2 agonists (LABA).