FDA Grants Priority Review for J&J’s Chewable Tablet Formulation

The US Food and Drug Administration (FDA) has granted priority review designation for Janssen Pharmaceuticals’ new drug application for a 500-mg 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.This designation shortens the review period to six months compared to 10 months for standard review by the FDA.

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. This development program was also one of Johnson & Johnson's commitments in the 2012 London Declaration on Neglected Tropical Diseases.

The 500-mg 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.

Source: Johnson & Johnson

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