December 2008 Issues

FDA Panel Recommends Two Inhaled Drugs No Longer be Used in Asthma

Summary: Internally, the FDA has been split about what to do about long-acting beta agonists (LABAs). Three FDA advisory committees, meeting together, recommended that GlaxoSmithKline’s Serevent and Novartis/Schering-Plough’s Foradil lose their indication for the treatment of asthma, though both drugs could continue to be marketed for other conditions. If the FDA doesn’t take away the asthma indication, the panel said the Serevent and Foradil labels should be changed to contraindicate use of either drug without an inhaled corticosteroid. Panel members also recommended that GlaxoSmithKline’s Advair and AstraZeneca’s Symbicort remain on the market, but they were undecided about continued use of Advair in children.

FDA to Clarify Regulations for Anti-Infective Drug Development

Summary: The FDA plans to issue new guidance for development of anti-infective drugs for cSSSI and uSSSI, based on the guidance of a recently convened Advisory Committee. It is likely that guidance will better define what types of infections should be included, set a 10% non-inferiority margin standard, and more. ♦ An FDA Advisory Committee recommended approval of Theravance/ Astellas’ telavancin for cSSSI, but most members believe it should have a Pregnancy Category X warning. ♦ The panel recommended against two other anti-infectives – Targanta’s Nuvocid (oritavancin) and Arpida’s iclaprim – saying they are promising but just haven’t shown sufficient efficacy, especially against MRSA . The panel recommended each company do another trial. Targanta is continuing with its drug, but iclaprim’s future is uncertain.