Roche's Tamiflu receives positive US regulatory opinion
27 December 2012 11:13 in Pharmaceutical Company Product News
Roche has announced that its well-established Tamiflu therapy for acute uncomplicated influenza has received US regulatory approval in an expanded indication.
The Food and Drug Administration has ratified the treatment for use among children aged two years and older, making it the only prescription oral antiviral medicine approved to treat people of all ages, from infants to elderly people.
Two open-label safety and pharmacokinetic studies conducted in 136 infants less than one year of age showed that Tamiflu delivered a similar safety and efficacy profile to that observed in older children and adults.
Dr Hal Barron, head of global product development and chief medical officer for Roche, said this new approval is important "particularly because the Centers for Disease Control advises against vaccinating infants less than six months of age".
To date, around 90 million people from more than 80 countries have received a prescription for Tamiflu to treat or prevent influenza, including more than 30 million children.
The drug was developed as part of a collaboration between Roche and Gilead Sciences.
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