U.S. FDA Grants Priority Review to Janssen’s New Drug Application - EMG

U.S. FDA Grants Priority Review to Janssen’s New Drug Application for Chewable Mebendazole Tablets Intended to Treat Soil-Transmitted Helminthiasis

Johnson & Johnson shows ongoing commitment to London Declaration on NTDs through advancement of new chewable tablet

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.

About soil-transmitted helminthiasis
Soil-transmitted helminthiasis (STH) is one of the most common infestations worldwide, affecting the most underserved communities. STH is transmitted by eggs present in human faeces which can contaminate soil in areas where sanitation is poor.v

STH can affect both children and adults, however, children are more at risk. Over 270 million preschool-age children and more than 600 million school-age children live in endemic areas and are in need of treatment and preventive interventions. The most common species that affect people are roundworm, whipworm and hookworm.v

To help lower the STH disease burden, the WHO recommends that preventative chemotherapy (PC) programs are carried out on a routine basis (in many cases twice a year) for at-risk people, particularly children, living in endemic areas.v

STH particularly impairs physical and cognitive development of affected children. It can also lead to health complications such as intestinal bleeding, loss of appetite, diarrhea and reduced absorption of micro- and macro-nutrients. In severe cases, STH can cause complications that require surgical intervention, such as intestinal obstruction and rectal prolapse, which can lead to death.vi

STH can also lead to poor school performance in children. Recovery from STH-associated morbidity is a long term process. The PC programs aim to keep STH infestations as low as possible to prevent morbidity and protect children during the critical phase of their development.

About mebendazole
Mebendazole interferes with cellular tubulin formation in intestinal worms which leads to the death of the worm.

About VERMOX® (mebendazole)
There are several registered formulations of mebendazole marketed by Janssen worldwide. Janssen’s 500mg VERMOX® solid oral tablet has been developed for the mass treatment of single or mixed intestinal infestations by Trichuris trichiura (whipworm), Ascaris lumbricoides(large roundworm) and Ancylostoma duodenale and Necator americanus (hookworm).

Important VERMOX® (mebendazole) safety information
VERMOX® is contraindicated in children below the age of one year. Convulsions in children, including infants below the age of one year have been reported very rarely. Adverse drug reactions with VERMOX® include abdominal discomfort, diarrhea, flatulence, and rash. No adverse reaction occurred in ≥1% of mebendazole-treated patients.

About Johnson & Johnson’s VERMOX® (mebendazole) donation commitment
In 2006, Johnson & Johnson founded Children Without Worms in collaboration with the Task Force for Global Health and started the donation of VERMOX®. The partnership is dedicated to the treatment and prevention of STH in children. WHO is the other critical partner that coordinates the global supply of medicines and facilitates distribution of the medicines via school programs in endemic countries.

In 2012, Johnson & Johnson endorsed the London Declaration on Neglected Tropical Diseases and committed to expanding the donation to 200 million doses of VERMOX® each year through 2020. If approved, the chewable tablet will replace the current solid tablet in donation programs.

For more information about Children Without Worms visit: http://www.childrenwithoutworms.org/

About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at @JanssenGlobal or@JNJGlobalHealth.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and donation commitments. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc., Johnson & Johnson and/or their affiliates. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product development, including the uncertainty of clinical success and of obtaining regulatory approvals; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2016, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The Janssen Pharmaceutical Companies, Johnson & Johnson and their affiliates do not undertake to update any forward-looking statement as a result of new information or future events or developments.


  1. U.S. Food and Drug Administration. Priority Review. Available at http://www.fda.gov/forpatients/approvals/fast/ucm405405.htm. Last accessed June 2016.
  2. World Health Organization. Preventive chemotherapy in human helminthiasis. Coordinated use of anthelminthic drugs in control interventions: a manual for health professionals and programme managers. Available at http://apps.who.int/iris/bitstream/10665/43545/1/9241547103_eng.pdf. Last accessed June 2016.
  3. Department of Health and Human Services, Food and Drug Administration. Report to Congress: Improving the Prevention, Diagnosis and Treatment of Rare and Neglected Diseases. March 2011. Available at http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/UCM265525.pdf. Last accessed June 2016.
  4. Janssen data on file.
  5. World Health Organization. Media centre. Soil-transmitted helminth infections. Available at http://www.who.int/mediacentre/factsheets/fs366/en/. Last accessed June 2016.
  6. World Health Organization, Intestinal worms. Available at http://www.who.int/intestinal_worms/more/en/. Last accessed June 2016.

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