FDA panel rejects GSK's Ariflo

A US Food and Drug Administration advisory committee has, by a 7-3 vote, decided to recommend against the approval of GlaxoSmithKline's Ariflo (cilomilast) for the treatment of chronic obstructive pulmonary disease. The decision was based on concerns over the efficacy of the agent, as well as gastrointestinal side effects.

Analysts at Natexis Bleichroeder believe the panel's verdict will result in the FDA issuing either a not-approvable letter for the phosphodiesterase-4 inhibitor or asking for additional clinical data, thereby delaying approval by possibly one or two years. Ariflo was submitted for approval in December 2002, already one year behind schedule, note the analysts.