Mixed news for high dose Advair from FDA

UK-based drug giant GlaxoSmithKline says that an advisory committee of the US Food and Drug Administration has unanimously agreed that the firm's drug Advair Diskus 500/50 (fluticasone propionate and salmeterol inhalation powder) cuts the risk of exacerbation in chronic obstructive pulmonary disease. However, the committee also concluded, nine votes to two, that the data did not provide substantial support for additional survival benefit claims.

Mixed data from TORCH study

The review examined data from the TORCH study that was submitted to support GSK's request for an expansion of the 500/50 formulation's indication (Marketletter March 5). Currently, the drug is approved for the treatment of asthma and, in the 250/50 dosage formulation, as a therapy for airflow obstruction in COPD associated with chronic bronchitis.