FDA:抗HIV药物获准用于某些婴儿
2013-05-15 佚名 MDC
圣路易斯(MD Consult)——2013年5月3日,百时美-施贵宝宣布,美国食品药品管理局(FDA)已批准扩大非核苷逆转录酶抑制剂Sustiva(依法韦仑)治疗人类免疫缺陷病毒1型(HIV-1)感染的适用范围。该药最初于1998年获准用于治疗年龄≥3岁、体重≥10 kg的HIV-1感染患者。从现在起,该药也可被用于年龄≥3个月、体重≥3.5 kg的婴儿。根据批准令,对这一人群可选择每日1次
圣路易斯(MD Consult)——2013年5月3日,百时美-施贵宝宣布,美国食品药品管理局(FDA)已批准扩大非核苷逆转录酶抑制剂Sustiva(依法韦仑)治疗人类免疫缺陷病毒1型(HIV-1)感染的适用范围。该药最初于1998年获准用于治疗年龄≥3岁、体重≥10 kg的HIV-1感染患者。从现在起,该药也可被用于年龄≥3个月、体重≥3.5 kg的婴儿。根据批准令,对这一人群可选择每日1次给药方案,对无法吞咽胶囊或药片的患者可采用分散型胶囊给药方法。
这项批准令是以3项开放标记研究的结果为依据的。这些研究招募了182例抗逆转录病毒初治和经治的HIV-1患者(年龄为3个月~21岁),评估了Sustiva联合其他抗逆转录药物中位治疗123周的药代动力学、安全性和抗逆转录病毒活性。结果显示,至研究结束时,在所有年龄段患者中均观察到了病毒学和免疫学应答。
在这3项儿科试验中观察到的不良反应与成人临床试验的观察结果相似,不同的是儿科患者中皮疹更常见(32%)且常常更严重。5例儿科患者因皮疹而退出研究。
不建议对年龄不足3个月或体重不足3.5 kg的患者使用Sustiva,原因是该药对于这类患者的安全性、药代动力学和抗逆转录病毒活性尚不明确,而且假如Sustiva用量不足,可能增加这类患者发生HIV耐药的风险。
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Bristol-Myers Squibb Receives US FDA sNDA Approval for Use of SUSTIVA® (efavirenz) in HIV-1 Infected Pediatric Patients
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: 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.
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