Bayer Seeks FDA Approval For New Formulation Of Nifurtimox
Zacks Investment Research | Jan 30, 2020 09:36PM ET
Bayer AG (DE:BAYGN) (OTC:BAYRY) announced that it has submitted an application to the FDA for a new formulation of nifurtimox to improve the body-weight adjusted dosing in pediatric Chagas patients. The application was supported by positive phase III data from the CHICO study, which is the largest clinical study to date in pediatric patients with Chagas disease.
Bayer filed the application on the World Neglected Tropical Diseases (NTDs) Day, which is part of Bayer’s Sustainability Strategy launched in December 2019.
The CHICO study evaluated the efficacy, safety and pharmacokinetics of nifurtimox in 330 pediatric patients with acute or chronic Chagas disease.
Chagas disease is caused by the protozoan parasite, Trypanosoma cruzi. The new formulation will improve dosing for newborns, infants and children suffering from Chagas disease and be a significant contribution in controlling the disease.
Shares of the company have gained 6.3% in the past year compared with the Zacks Investment Research
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