Pharmaceutical Business review

Roche seeks extended approval of influenza drug

The drug is already indicated for the treatment of influenza in children aged one year and above, but not yet for use as a preventative in this age group. It is also approved for treatment and prevention in adults. It works by blocking an enzyme on the surface of the virus which prevents it infecting other cells in the body.

Roche is optimistic that the Committee for Medicinal Products for Human Use (CHMP) will complete their review of the application before the end of the year. A filing for the same indication has already been submitted in the US in April this year.

“It is important that the protection provided by Tamiflu can be extended to include young children because not only are children more likely to suffer from the symptoms of influenza, but they are also a major cause of viral spread during a seasonal epidemic,” said William Burns, CEO of Roche’s pharma division.

Meanwhile, in animal tests, Tamiflu has been shown to suppress the newest strain of avian, or “bird”, flu, that has broken out in poultry in China, Vietnam, and Cambodia. Experts fear that the mutating virus has the potential to spread amongst humans and cause a flu pandemic.

Researchers have found that the new strain of the virus is more virulent than the strain that killed six people in Hong Kong in 1997.