關鍵詞： 百時美施貴寶 Sustiva HIV感染

2013年5月7日訊 /生物谷BIOON/ --百時美施貴寶（BMS）昨日宣布，藥物Sustiva（efavirenz,，依非韋倫）補充新藥申請（sNDA）獲FDA批準,，包括用于體重至少為3.5公斤的3個月至3歲HIV-1感染的小兒患者的推薦劑量。該項批準,，為這一患者群體提供了一個每日一次的治療選擇,，同時也為那些無法吞咽膠囊或片劑的患者提供了一種膠囊微粒（capsule sprinkle）服藥方法。

Sustiva是一種非核苷類逆轉(zhuǎn)錄酶抑制劑（NNRTI）,，最初于1998年獲FDA批準用于治療3歲及以上,、體重至少10公斤的HIV-1感染者，該藥不適用于對efavirenz或其任何成分過敏的患者,。（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.

(責任編輯：jie.jiang)