Chemo Research, S. L. awarded first US FDA approval for benznidazole to treat Chagas disease.
M2 EQUITYBITES-August 30, 2017-Chemo Research, S. L. awarded first US FDA approval for benznidazole to treat Chagas disease
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The U.S. Food and Drug Administration (FDA) reported on Tuesday that it has awarded healthcare company Chemo Research, S. L. with accelerated approval for benznidazole to be used in children ages 2 to 12 years old with Chagas disease or American trypanosomiasis.
In the US, Benznidazole is reportedly the first treatment approved for Chagas disease, which is a parasitic infection caused by Trypanosoma cruzi and can be transmitted through contact with the faeces of a certain insect, blood transfusions, or from a mother to her child during pregnancy. The disease can cause serious heart illness and can affect swallowing and digestion.
According to the FDA, the safety and efficacy of benznidazole were established in two placebo-controlled clinical trials in pediatric patients six to 12 years old.
Approximately 60% of children treated with benznidazole had an antibody test change from positive to negative compared with approximately 14% of children who received a placebo in the first trial. Approximately 55% of children treated with benznidazole had an antibody test change from positive to negative compared with 5% who received a placebo second trial.
An additional study of the safety and pharmacokinetics (how the body absorbs, distributes and clears the drug) of benznidazole in pediatric patients two to 12 years of age provided information for dosing recommendations down to two years of age.
The FDA is an agency within the U.S. Department of Health and Human Services that works to assure the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices to protect public health.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Aug 30, 2017|
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