FDA批准首个静脉抗流感制剂帕拉米韦

美国食品和药品管理局（FDA）2014年12月22日公布，帕拉米韦（神经氨酸酶抑制剂静脉注射制剂）已被批准用于治疗18岁以上、“流感症状出现不超过2天”的急性单纯型（无并发症）流感。

该药物为单次静脉注射剂量，并且将被命名为Rapivab由BioCryst制药负责上市和销售。

“Rapivab是FDA批准用于治疗流感感染的第3个神经氨酸酶抑制剂，但是第1个被批准的静脉制剂，” FDA药品评估与研究中心的抗菌产品办公室主任Edward Cox医生发表声明时说到。该药物可抑制使感染细胞释放病毒颗粒的病毒神经氨酸酶。

“该种单剂量静脉制剂为医护人员和患者根据各自需要治疗急性单纯型流感的提供了可行的选择，”他补充说。

该药物得到批准是基于一项纳入297例确诊为甲型流感并被随机分配至300mg或600mg帕拉米韦，或安慰剂组的临床研究结果。

“总体上，接受Rapivab 600mg治疗的患者其流感症状在21小时内得到缓解，平均比安慰剂组更快，”和600mg剂量组患者“约12小时可恢复正常体温，与安慰剂组相比更早，”声明称。这些结果得到支持性研究的证实，但“其对需要住院治疗的严重流感患者的疗效并不明确，”声明补充到。

FDA还提到，腹泻是帕拉米韦相关的常见不良事件之一；罕见、严重的不良事件包括严重的皮肤或过敏性反应，如Stevens-Johnson综合征（史—约综合征）和多形性红斑。

之前被批准的2个神经氨酸酶抑制剂分别是作为口服制剂的奥司他韦（达菲）和和作为吸入制剂的扎那米韦（乐感清）。

爱思唯尔版权所有  未经授权请勿转载

By: ELIZABETH MECHCATIE, Ob.Gyn. News Digital Network

Peramivir, an intravenously administered neuraminidase inhibitor, has been approved for treating acute uncomplicated influenza in adults aged 18 years and older, who “have shown symptoms of flu for no more than two days,” the Food and Drug Administration announced on Dec. 22.*

It is administered as a single IV dose, and will be marketed as Rapivab, by BioCryst Pharmaceuticals.

“Rapivab is the third neuraminidase inhibitor approved by the FDA to treat flu infection, but the first approved as an IV formulation,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the statement. The drug inhibits the viral neuraminidase, which releases virus particles from infected cells.

Approval was based on a study of 297 people with confirmed influenza, randomized to 300 mg or 600 mg of peramivir, or placebo.“The availability of a single-dose, intravenous option for the treatment of acute uncomplicated flu allows health care professionals and patients to have a choice based on an individual patient’s needs,” he added.

 “Overall, participants receiving Rapivab 600 mg had their combined influenza symptoms alleviated 21 hours sooner, on average, than those receiving placebo, which is consistent with other drugs in the same class,” and those on the 600 mg dose “also recovered to normal temperature approximately 12 hours sooner compared to placebo,” the statement said. These findings were confirmed in supportive studies, but “efficacy could not be established in patients with serious influenza requiring hospitalization,” the statement added.

Diarrhea was among the common adverse events associated with peramivir; rare, serious adverse events included serious skin or hypersensitivity reactions such as Stevens-Johnson syndrome and erythema multiforme, according to the FDA.

The two previously approved neuraminidase inhibitors are oseltamivir (Tamiflu), which is administered orally, and zanamivir (Relenza), which is inhaled.