Switzerland’s Roche says that it is seeking approval in Europe for smaller child-sized capsules of the antiviral Tamiflu, at a time when many governments have been stockpiling as an initial defence in the event of the pandemic.
The firm has filed an application with the European Medicines Agency requesting an extension of the current Tamiflu (oseltamivir) licence to include smaller capsules of 30mg and 45mg in addition to the 75mg capsule already registered. Roche says that these lower dosage strengths have been developed mainly for use in children for seasonal and pandemic influenza, as an alternative to the suspension formulation, adding that they 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 the EMEA will complete its evaluation by mid-year, while an application is also expected to be filed with the US Food and Drug Administration shortly. Explaining the rationale behind the filing further, Roche said that the smaller capsules will be “an important component in government pandemic preparedness” as they provide “a better option for stockpiling for paediatric use, given the longer shelf life compared to paediatric suspension.”
It noted that a number of governments have stockpiled the active pharmaceutical ingredient (API) as an option in the event of a pandemic but “the preparation of the API into a drinking solution is logistically more challenging and time-consuming than distributing capsules.” The firm added that it has received and fulfilled pandemic orders for Tamiflu from more than 75 countries and Finland has already exchanged all of its API for capsules.