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【资讯翻译】U.S. FDA Grants Priority Review to Janssen’s New Drug App...

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发表于 2016-7-26 09:29:20 | 显示全部楼层 |阅读模式
U.S. FDA Grants Priority Review to Janssen’s New Drug Application for Chewable Mebendazole Tablets Intended to Treat Soil-Transmitted Helminthiasis

BEERSE, BELGIUM – July 13, 2016 – Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for a 500mg chewable tablet formulation of mebendazole.  If approved, the chewable mebendazole tablet will provide a treatment and prevention alternative for adults and children aged one year or older with soil-transmitted helminthiasis (STH), also known as intestinal worm infestations.

The FDA grants Priority Review to therapies that, if approved, may offer significant improvements in the treatment, diagnosis or prevention of a serious condition.i This designation shortens the review period to six months compared to 10 months for Standard Review.

“The introduction of a child-friendly formulation of mebendazole is a recognized global health need. Our team has worked to address this need through the development of the chewable mebendazole tablet, and our efforts have been bolstered with the receipt of a Priority Review,” said Wim Parys, M.D., Global Head R&D, Global Public Health, Janssen. “Upon approval of a new formulation, Johnson & Johnson will replace its current mebendazole solid tablet with the chewable version in its donation program which provides free worm treatment and prevention for people in high burden countries.”

The development of the new chewable tablet responds to recommendations by the World Health Organization (WHO) calling for a more child-friendly formulation of mebendazole to effectively treat young children and their families. Specifically, the WHO recommends only chewable deworming tablets be given to children.ii This development program was also one of Johnson & Johnson’s commitments in the 2012 London Declaration on Neglected Tropical Diseases.

The 500mg chewable mebendazole tablet can be chewed by children without the need for potable water, providing a treatment and prevention option for children too young to swallow a solid tablet. In addition, with a small amount of water, the tablet can form a soft mass which can be swallowed by children as young as one year old, addressing another key unmet need.

“STH is considered a Neglected Tropical Disease by the WHO and the U.S. FDA.iii It affects around two billion people worldwide, impacting the most vulnerable communities,” said William Lin, Program Director, Neglected Tropical Diseases, Johnson & Johnson. “Johnson & Johnson is committed to donating 200 million doses of mebendazole tablets each year through 2020, to help reduce the burden of this disease. We remain committed to helping control and eliminate STH as a public health problem.”

The NDA submission is supported by data from 712 participants across four clinical trialsiv, most of whom were children with single or mixed intestinal worm infestations.


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发表于 2016-7-26 11:09:09 | 显示全部楼层
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