Roche files European application for smaller Tamiflu capsules

Swiss pharmaceutical firm Roche is seeking permission for European regulators to extend its current Tamiflu licence to include smaller 30 mg and 45 mg capsules. It currently has 75 mg doses registered for sale.

Lower dosages have been developed by the pharmaceutical firm to treat children and for seasonal and pandemic influenza, but would also prove useful in treating the elderly, or patients that are not able to swallow the 75 mg drugs, Roche said.

Furthermore, smaller capsules could be “an important component in government pandemic preparedness”, the company noted, claiming they provide an improved option for stockpiling.

An accelerated review has been granted and the group asserts confidence that the European Agency for the Evaluation of Medicinal Products will have completed the necessary assessments by the summer. A further application with the US Food and Drug Administration is planned for the future.

Roche noted that manufacturing would remain unchanged: “The only change will be the size of the capsule and the amount of the active ingredient, oseltamivir, filled into the capsule,” it said in a statement.