Roche has received a positive opinion in Europe from the Committee of Human Medicinal Products (CHMP) recommending marketing authorization for Tamiflu (oseltamivir) capsules of 30 mg and 45 mg doses.
Until now, Tamiflu was only available in capsules containing a 75 mg dose of oseltamivir and as a powder for oral suspension. The lower dose capsules provide a convenient alternative for the treatment and prevention of influenza types A and B in patients one year and older. Since the capsules have a longer shelf life than the suspension formulation currently used for children (five years vs. two years), they also offer an improved option for government pandemic stockpiling.
An approval for lower dose capsules was recently granted by the US Food and Drug Administration (FDA), a Roche press release stated.
The application for lower dose capsules was filed in February 2007 based on data 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, oseltamivir, filled into the capsule. The small capsules have longer stability and require considerably less storage space than the currently available paediatric dry suspension. This is critical given the volumes of drug that must be stored and will also facilitate easier distribution in the event of a pandemic.
Tamiflu, an oral neuraminidase inhibitor, is designed to be active against all clinically relevant influenza viruses. It works by blocking the action of the neuraminidase enzyme on the surface of the virus. When neuraminidase is inhibited, the virus is not able to spread to and infect other cells in the body. Tamiflu is the only member of the neuraminidase class of drugs approved for use in treatment and prevention of influenza in children 1 to 5 years of age.
Influenza is particularly dangerous for the most vulnerable and this includes young children and infants .Children younger than two years old are as likely as those over age 65 to be hospitalized because of influenza. It is estimated that children are three times more likely to get sick with the flu - on average, one in 10 adults is affected by influenza annually, compared with one in three children. There is a high need for influenza treatments for children as they are more severely affected by seasonal influenza compared to adults.
Tamiflu was invented by Gilead Sciences and licensed to Roche in 1996. Roche and Gilead partnered on clinical development, with Roche leading efforts to produce, register and bring the product to the markets. Under the terms of the companies' agreement, amended in November 2005, Gilead participates with Roche in the consideration of sub-licenses for the pandemic supply of oseltamivir. To ensure broader access to Tamiflu for all patients in need, Gilead has agreed to waive its right to full royalty payments for product sold under these sub-licenses.