关键词: 百时美施贵宝 Sustiva HIV感染
2013年5月7日讯 /生物谷BIOON/ --百时美施贵宝(BMS)昨日宣布,药物Sustiva(efavirenz,依非韦伦)补充新药申请(sNDA)获FDA批准,包括用于体重至少为3.5公斤的3个月至3岁HIV-1感染的小儿患者的推荐剂量。该项批准,为这一患者群体提供了一个每日一次的治疗选择,同时也为那些无法吞咽胶囊或片剂的患者提供了一种胶囊微粒(capsule sprinkle)服药方法。
Sustiva是一种非核苷类逆转录酶抑制剂(NNRTI),最初于1998年获FDA批准用于治疗3岁及以上、体重至少10公斤的HIV-1感染者,该药不适用于对efavirenz或其任何成分过敏的患者。(生物谷bioon.com)
英文原文:
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-na?ve 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)
INDICATION:
SUSTIVAis a prescription medicine used with other antiretroviral medicines to help treat HIV-1 infection in adults and children 3 months or older who weigh at least 3.5 kg (7 lbs 12 oz).
SUSTIVA does not cure HIV or AIDS and you may continue to experience illnesses associated with HIV-1 infection, including opportunistic infections.
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