|[December 21, 2012]
Genentech Announces FDA Approval of Tamiflu for the Treatment of Influenza in Infants
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
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.
Tamilu, 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
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
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