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news.Roche has filed an application with regulatory authorities in Europe requesting an extension of the current Tamiflu license to include smaller capsules of 30mg and 45mg, in order to provide protection form influenza in children.
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These lower dosage strengths are in addition to the 75mg capsule already registered and have been developed mainly for use in children for seasonal and pandemic influenza, as an alternative to the suspension formulation. They provide easier and more convenient dosing. Tamiflu small capsules would also be useful in the elderly or other adults that have difficulty swallowing the 75mg capsule.
Roche has been granted an accelerated review and is optimistic that EU health authorities will complete their evaluation by mid-year. An application will also be filed with the Food and Drug Administration in the US shortly.
As well as being used to manage seasonal influenza, the smaller capsules will be an important component in government pandemic preparedness. According to Roche, they provide a better option for stockpiling for pediatric use, given the longer shelf life compared to pediatric suspension.