Bristol-Myers Squibb Company BMY today announced that the U.S. Food
and Drug Administration (FDA) has approved a supplemental new drug application
(sNDA) for SUSTIVA^® (efavirenz), including dosing recommendations for HIV-1
infected pediatric patients three months to three years old and weighing at
least 3.5 kg. This approval offers a once-daily option as part of a regimen
for this population and includes a “capsule sprinkle” administration method
for patients who cannot swallow capsules or tablets. Detailed information
about the “capsule sprinkle” method is provided in the ‘Instructions for Use'
at the end of the Patient Information section of the Package Insert.
SUSTIVA is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that was
originally approved in the U.S. in 1998 to treat HIV-1 infected children three
years of age or older and weighing at least 10 kg. SUSTIVA is not to be taken
by patients who are allergic to efavirenz, or to any of its ingredients.
“Bristol-Myers Squibb recognizes the importance of offering alternative
methods of administration of HIV medicines, including for pediatric patients
who cannot swallow tablets or capsules, and their caregivers who help manage
their treatment,” said Brian Daniels, M.D., Senior Vice President, Global
Development and Medical Affairs. “This approval is one example of our enduring
commitment to the HIV patient community.”
This sNDA was based on results from three open-label studies that evaluated
the pharmacokinetics, safety, and antiretroviral activity of SUSTIVA in
combination with other antiretroviral agents in 182 antiretroviral-naïve and
–experienced HIV-1 infected pediatric patients (three months to 21 years of
age) for a median of 123 weeks. Virologic and immunologic response was
observed across all ages at the end of the studies, as measured by HIV RNA and
CD4 cell count.
The adverse reactions observed in the three pediatric trials were similar to
those observed in clinical trials in adults, except that rash was more common
in pediatric patients (32 percent for all grades regardless of causality) and
more often of higher grade (i.e., more severe). Five pediatric patients (2.7
percent) discontinued from the study because of rash. Use of SUSTIVA
(efavirenz) in patients younger than three months of age OR less than 3.5 kg
body weight is not recommended because the safety, pharmacokinetics and
antiretroviral activity of SUSTIVA have not been evaluated in this age group
and there is a risk of developing HIV resistance if SUSTIVA is underdosed.
Bristol-Myers Squibb remains at the forefront of HIV/AIDS research and
continues to pursue the development of treatment options for children and
adults with HIV. Studies are ongoing for new treatments, including an NRTI
(BMS-986001), an attachment inhibitor (BMS-663068) and a maturation inhibitor.
Bristol-Myers Squibb is also developing a fixed-dose combination of atazanavir
sulfate and Gilead's investigational drug cobicistat.
INDICATION and IMPORTANT SAFETY INFORMATION for SUSTIVA^® (efavirenz)
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