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Biocryst流感注射剂获FDA批准

来源:生物谷 2014-12-23 13:30

2014年12月23日讯/生物谷BIOON/--近日,FDA批准了Biocryst制药的静脉注射流感药物,使得该公司的股票在上市前交易中上涨了将近10%。

该流感药物适用于患有急性无并发症流感、并且可能无法服用口服药(如吉利德的达菲)或是无法使用吸入剂(如葛兰素史克的乐感清)的成人。

Needham & Co的分析师Serge Belanger认为,静脉注射药物能够确保患有严重流感的病人接受适当的用药剂量,而这对于口服药或是吸入剂也是需要考虑的。

Biocryst的帕拉米韦注射剂,将会以Rapivab的商品名销售,据该公司负责人声称,这是FDA在过去15年内批准的第一个抗病毒流感治疗药物。

Rapivab能够抑制神经氨酸苷酶,这种酶对流感的传播至关重要。

有分析师认为,尽管Rapivab的商业潜力有限,因为主要是用于住院患者,通常库存订单都会驱动销量,因此销售应该不成问题。

Roth Capital Partner的分析师Ed Arce估计,2015年第一季度,Biocryst会从美国卫生和人类服务部(HHS)获得1.2亿美元的库存订单。

对于表现出流感症状、且发病时间在2天之内的成年患者,推荐剂量是一支600mg剂量的Rapivab静脉滴注15—30分钟。

Biocryst曾与HHS的生物医学高级研发机构签订了2.348亿美元的合同,用于研发Rapivab。在2009年H1N1流感猖獗时期,该药曾获得紧急使用授权。

该药物在2010年1月份曾由Shionogi & Co Ltd在日本上市,当时的商品名为Rapiacta;2011年,该药物在韩国获批,用于治疗流感、猪流感和禽流感。

BioCryst正在与国家过敏与传染病研究所合作研发一种广谱的抗病毒药物——BCX4430,用于抵抗那些对健康和国家安全造成极大威胁的病毒,包括埃博拉病毒。

上周五,BioCryst在纳斯达克的收盘价是11.16美元。(生物谷Bioon.com)

原文 FDA approves BioCryst's intravenous flu drug

The U.S. Food and Drug Administration approved Biocryst Pharmaceuticals Inc's intravenous flu drug, sending the company's shares up nearly 10 percent in premarket trading.

The single-dose drug is for adults who have acute uncomplicated influenza and may be unable to swallow pills, such as Gilead Sciences Inc's Tamiflu, or inhale GlaxoSmithKline Plc's Relenza.

"An IV (intravenous) drug would ensure that an appropriate dose is administered, which is a concern for oral and inhaled drugs in severely ill patients," Needham & Co analyst Serge Belanger said.

Biocryst's peramivir injection, to be sold as Rapivab, is the first antiviral influenza treatment approved by the FDA in fifteen years, the company said on Monday.

Rapivab inhibits the enzyme neuraminidase, which is critical to the spread of influenza.

The drug has limited commercial potential, as it is designed for use in hospitalized patients. But stockpiling orders are likely to drive sales, analysts said.

Roth Capital Partner analyst Ed Arce estimated a $120 million stockpiling order from the U.S. Department of Health and Human Services (HHS) in the first quarter of 2015.

A single 600 mg dose of Rapivab via intravenous infusion for 15 to 30 minutes is recommended for adults who have shown flu symptoms for no more than two days, the company said.

Rapivab was developed under a $234.8 million contract from Biomedical Advanced Research and Development Authority of the HHS. It was granted an "emergency use authorization" during the October 2009 swine flu pandemic.

The drug was launched in Japan in January 2010 by Shionogi & Co Ltd under the name Rapiacta. Later that year, it received approval in South Korea to treat influenza, and for use against swine and bird flu.

BioCryst is also developing a broad-spectrum anti-viral, BCX4430, with the National Institute of Allergy and Infectious Diseases, for viruses that pose a threat to health and national security, including Ebola.

The biotechnology company's stock closed at $11.16 on the Nasdaq on Friday.

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