ROCHE GETS ACCELERATED REVIEW IN EUROPE FOR NEW TAMIFLU DOSES

The European Medicines Agency (EMEA) has granted Roche an accelerated review of its flu drug Tamiflu. The company said it "is optimistic that EMEA will complete their evaluation by midyear."

The application the company has filed requests an extension of the current Tamiflu (oseltamivir) license to include smaller capsules of 30 and 45 mg in addition to the 75-mg capsule already registered. The company developed the lower dosage strengths mainly for use in children for seasonal and pandemic influenza as an alternative to the suspension formulation. Tamiflu small capsules could also be useful in the elderly or other adults who have difficulty swallowing the 75-mg capsule, the company said.

The European application was based on information already available for the 75-mg capsule. The method of manufacturing will remain the same, and the only change will be the size of the capsule and the amount of the active ingredient. Roche said it will file an application with the FDA "shortly."