SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has extended the approval of Tamiflu® (oseltamivir phosphate) for the treatment of acute, uncomplicated influenza to include infants two weeks of age and older.i Tamiflu is prescribed by doctors to help lessen the duration and severity of influenza by blocking the virus’ ability to replicate in the body.
The approval makes Tamiflu the only prescription oral antiviral medicine approved to treat people of all ages, from infants two weeks of age to elderly people. Tamiflu was first approved in the United States over 13 years ago.i Approximately 30 million children worldwide over the age of one, including an estimated 6.9 million children in the United States, have received a prescription for Tamiflu.ii
“We are very pleased that this approval provides parents with a medicine for children as young as two weeks old, particularly because the CDC advises against vaccinating infants less than six months of age,” said Hal Barron, M.D., chief medical officer and head, Global Product Development.
The FDA approval is based on two open label safety and pharmacokinetic studies conducted in 136 infants less than one year of age infected with influenza, which assessed how Tamiflu was absorbed and distributed in the body and how well it was tolerated in this group.i Based on these studies, a 3 mg/kg dose of Tamiflu given twice daily for five days to infants is expected to have a similar safety and efficacy profile to that observed in older children and adults. The clinical trials showed that the safety profile in infants less than one year of age was consistent with other populations.
Tamiflu, co-developed by Gilead Sciences Inc, works by blocking the action of the neuraminidase enzyme on the surface of the influenza virus. When neuraminidase is inhibited, the virus is restrained from spreading to other cells in the body.
Tamiflu is indicated for the treatment of acute, uncomplicated illness due to influenza infection in people two weeks of age and older who have been symptomatic for no more than two days. Tamiflu is also indicated for preventing influenza in patients one year and older. Tamiflu is not indicated for preventing influenza in children younger than one year of age. Tamiflu is not a substitute for the annual influenza vaccination.
Important Safety Information
Before taking Tamiflu, patients should tell their doctor if they are pregnant or nursing, or if they have kidney disease, heart disease, respiratory disease, or other serious health conditions. Also, patients should let their doctor know if they are taking any other medications or if they have received nasally administered influenza virus vaccine during the past two weeks.
If patients develop an allergic reaction or a severe rash, they should stop taking Tamiflu and contact their healthcare professional immediately, as it may be very serious. People with the flu, particularly children and adolescents, may be at an increased risk of seizures, confusion, or abnormal behavior early during their illness. These events may occur shortly after beginning Tamiflu or may occur when flu is not treated. These events are uncommon but may result in accidental injury to the patient. Therefore, patients should be observed for signs of unusual behavior and a healthcare professional should be contacted immediately if the patient shows any signs of unusual behavior.
The most common side effects of TAMIFLU when used for treatment of influenza include nausea and vomiting.
The most common side effects of TAMIFLU when used for prevention of influenza include nausea, vomiting, diarrhea, and stomach (abdomen) pain.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Patients and caregivers may also report side effects to Genentech at (888) 835-2555.
For additional important safety information, please visit http://www.tamiflu.com.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
i Tamiflu® (oseltamivir phosphate) Prescribing Information.
December 21, 2012
ii Roche Data on File