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FDA Approves Efavirenz (Sustiva) for HIV+ Children Ages 3 Months to 3 Years

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The U.S. Food and Drug Administration (FDA) announced on May 3 that it has approved a supplemental new drug application for use of efavirenz (Sustiva) by infants and young children with HIV. The new dosing recommendation includes the option to sprinkling capsule contents on food for children who are unable to swallow pills.

Efavirenz -- a non-nucleoside reverse transcriptase inhibitor (NNRTI) that is also a component of the Atripla single-tablet regimen -- was initially approved in 1998 for adults and children over 3 years old.

Below is an edited excerpt from a press release issued by Sustiva producer Bristol-Myers Squibb describing the approval in more detail. The full release, including indication and important safety information about Sustiva, is available online. Full Prescribing Information is also available.

Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of SUSTIVA (efavirenz) in HIV-1 Infected Pediatric Patients

  • Approval offers a once-daily option as part of a regimen for HIV-1 infected infants as young as three months and weighing at least 3.5 kg
  • "Capsule sprinkle" administration allows dosing in patients who cannot swallow capsules or tablets

Princeton, N.J. -- May 3, 2013 -- Bristol-Myers Squibb Company 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, MD, 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-naive 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.

Please see Full Prescribing Information.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines. For more information, please visit http://www.bms.comor follow us on Twitter at http://twitter.com/bmsnews.

5/3/13

Source

Bristol-Myers Squibb. Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of SUSTIVA (efavirenz) in HIV-1 Infected Pediatric Patients. Press release. May 3, 2013.