流感藥: Inavir® ( Dry Powder Inhaler). :approved for sale in Japan

Inavir® is the first drug of a new class of long acting neuraminidase inhibitors (LANIs) to address the limitation of the current products, which require daily or more frequent dosing. The new class provides the opportunity to medicate patients on a "one and done" basis and offers a number of potential benefits. These include that the patient is more likely to use the product properly and as intended and also offers a reduced cost of storage and transport per course, where the product is intended to be stockpiled. Inavir® is Daiichi Sankyo's registered brand for laninamivir octanoate, also previously known as CS-8958. Inavir® is delivered via a Dry Powder Inhaler. Inavir® is not a vaccine.

Neuraminidase inhibitors Neuraminidase is essential for the replication of all influenza viruses.  It is an enzyme which allows new viruses to be released from the infected lung cells, further extending the infection.  Neuraminidase inhibitors block this activity, preventing the release and spread of new viruses.

Development and commercialization Biota and Daiichi Sankyo co-own a range of second generation influenza anti-virals, of which Inavir® is the lead product. Under the co-ownership agreement, Daiichi Sankyo held an option to manufacture and sell laninamivir in Japan, in return for funding an extensive range of Japanese clinical trials. Biota will receive royalties on all sales of Inavir® and may qualify for additional milestone payments. Biota and Daiichi Sankyo are exploring options for development and commercialisation of laninamivir ex-Japan.

Regulatory approval Inavir® is approved for sale in Japan for the treatment of influenza in adults and children.

日本：第一三共证实“Inavir®”可预防流感病毒传染病 2012-08-23 17:54 来源：财经网 据日本媒体报道，日本第一三共公司(Daiichi Sankyo Company, Limited)为了验证抗流感病毒药物“Inavir®”(通用名称：Laninamivir Octanoate Hydrate，暂译为拉尼娜米韦辛酸酯水合物)在预防流感病毒传染病方面的效果，进行了三期临床试验。据了解，第一三共以与A(甲)型或B(乙)型流感病毒传染病患者同住的家属或共同生活者为对象，进行了随机双盲安慰剂对照试验。 2012年8月22日，第一三共发布消息称，试验结果显示，在作为预防有效性的主要评价指标流感病毒传染病的临床发病率方面，从统计学上来说，“Inavir®”使用组的发病率显著低于安慰剂使用组(即非偶然出现的差异)，证实了使用“Inavir®”具有制止流感病毒传染病发病的效果。而且，安全性方面也没有问题。另外，实际的病例数及有关效果的具体数值等详细结果预定于今后在相关学术杂志或学会上公布，具体时间待定。今后，第一三共为了在2012年内申请到“Inavir?”的制造、销售批准(适用于预防流感病毒传染病)，将不断推进各项准备工作。据了解，“Inavir®”是第一三共创制的纯日本产长效神经氨酸酶抑制剂，于2010年9月10日作为A型或B型流感病毒传染病的治疗药物取得了制造、销售批准，并于同年10月19日开始销售。(责任编辑：尹萍)来源元培产业情报)

다이이찌산쿄는 독감치료제 '이나비르'(Inavir, laninamivir)에 대해 연내 독감 예방제로 승인을 신청할 계획이라고 발표했다. 일본에서 시판되고 있는 독감치료제는 이나비르 외에 쥬가이제약의 '타미플루', 글락소스미스클라인(GSK)의 '리렌자', 시오노기제약의 '래피액타'(Rapiacta, Peramivir)가 있는데, 이 가운데 타미플루와 리렌자는 예방적응증을 이미 취득했다.  다이이찌산쿄에 따르면 예방적응증으로 실시해 온 3상 임상시험에서는 A형이나 B형 독감바이러스 감염환자와 동거인, 공동생활자를 이나비르 투여그룹과 위약 그룹으로 나눠 비교했다. 그 결과, 독감 발병률은 이나비르 투여그룹이 위약그룹에 비해 통계학적으로 유의하게 낮은 한편, 안전성 문제도 나타나지 않은 것으로 확인됐다. 이나비르는 A형과 B형 독감에 효과가 있는 성인과 소아용 흡입제. 타미플루가 하루 2회(성인) 5일간 복용할 필요가 있는 반면, 이나비르는 1회 흡입으로 효과를 보이는 특징이 있다.