GlaxoSmithKline gets Seretide endorsement from CHMP

GlaxoSmithKline has revealed it is “delighted” with the European Committee for Medicinal Products for Human Use (CHMP) because of its positive opinion of Seretide dosages. Seretide, an asthma drug, is targeted at patients with moderate and persistent asthma and it is known as Advair in the US. It contains two active ingredients: fluticasone propionate and salmeterol.

The company says that the new dosage recommendations agreed upon will help doctors prescribe the drug effectively, if approved by the main regulatory body, the EU Commission. Glaxo added that the new measures would make it easier for clinicians to prescribe a starting dosage for new patients.

Kate Knobil MD, vice president of respiratory clinical development, remarked: “We are delighted that the CHMP has 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 inhaled corticosteroids/long-acting beta-2 agonist combination with guidance on use as an initial maintenance therapy,” she concluded. Glaxo says the recommended treatment for moderate and persistent asthma is generally in the form of inhaled corticosteroids and long-acting beta-2 agonists, as daily controllers.

According to charity Asthma UK, some 5.2 million Britons suffer from asthma, including 1.1 million children. Prevalence of asthma has risen in the last few days, perhaps because of changing diets and environmental pollution, according to the charity. It adds that adult onset asthma can sometimes follow a viral infection.

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