Janssen’s New Drug Application for drug to treat intestinal worms gets US FDA priority review
pharmafile | July 14, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Johnson & Johnson, US FDA, WHO, drug trial, new drug application, regulation, soil-transmitted helminthiasis
Johnson & Johnson (NYSE: JNJ) said the US Food and Drug Administration (FDA) has granted Priority Review for its New Drug Application (NDA) for its drug to treat intestinal worm infestations.
The company said the 500mg chewable mebendazole tablet will provide a treatment and prevention alternative for soil-transmitted helminthiasis (STH).
Wim Parys, global head R&D, global public health, Janssen, said: “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. 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, the company said in a statement.
William Lin, program director, neglected tropical diseases, Johnson & Johnson, said: “STH is considered a Neglected Tropical Disease by the WHO and the US FDA. It affects around two billion people worldwide, impacting the most vulnerable communities. 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.”
Mebendazole interferes with cellular tubulin formation in intestinal worms which leads to the death of the worm.
Anjali Shukla
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