Thu, Mar 5, 2015, 2:01 AM EST - U.S. Markets open in 7 hrs 29 mins

Recent

% | $
Quotes you view appear here for quick access.

BioCryst Pharmaceuticals, Inc. Message Board

  • maphere maphere Dec 21, 2012 2:25 PM Flag

    Tamiflu approved for infants...

    The FDA said its expanded use is based on extrapolating data from previous study results in adults and older children, and supporting studies by the U.S. National Institutes of Health and Roche.
    ____________________

    OK FDA, now extrapolate the IV P data already!

    Good sign I would say for Peramivir.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • would some one post a succesful Peramivir trial conducted by the EFDEAa?

    • Although there is a fixed dosing regimen for patients 1 year and older according to weight categories, the dosing for children younger than 1 year must be calculated for each patient based on their exact weight. These children should receive 3 milligrams per kilogram twice daily for five days.

      These smaller doses will require a different dispenser than what is currently co-packaged with Tamiflu.

      “Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight.”

      Tamiflu is the only product approved to treat flu infection in children younger than 1 year old, providing an important treatment option for a vulnerable population. According to the Centers for Disease Control and Prevention (CDC), children younger than 2 years are at higher risk for developing complications from the flu, with the highest rates of hospitalization in those less than 6 months of age.

      The FDA expanded the approved use of Tamiflu in children younger than 1 year based on extrapolation of data from previous study results in adults and older children, and additional supporting safety and pharmacokinetic studies sponsored by both the National Institutes of Health and Roche Group, Tamiflu’s manufacturer.

      Pediatric legislation1 permits efficacy to be extrapolated from previous study results in adults and older children if the illness being studied and the effects of the drug are sufficiently similar in adult and pediatric patients. Data on how the drug is metabolized in the body (pharmacokinetic data) indicated a dose of 3 mg/kg twice daily provided concentrations of Tamiflu similar to those observed in older children and adults, and is expected to provide similar efficacy in this very young age group.

      Almost all of the 135 pediatric patients enrolled in the two safety studies had confirmed flu. Results from these studies showed the safety profile in children younger than 1 year was consistent with the established safety profile of adults and older children. The most common side effects reported with Tamiflu use in this age group include vomiting and diarrhea.

    • Hey, guys. No money no talk. If you don't bring me to lunches (I mean big dinners) and you don't give me GIFTS. THEN DON'T ASK ME TO DO ANYTHINGS!!!

    • Yeah, and you still have the problem - how do you give this capsule to an infant - break open, measure, insert in some other liquid medium, hope for absorption. FDA knows they have an infant flu problem, but are they prepared to act decisively to solve it or not? Just posted the early rise in pediatric flu cases from Friday CDC Fluview update.

 
BCRX
10.49+0.43(+4.27%)Mar 4 4:00 PMEST

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.