FDA approves first treatment for the ‘silent killer’
pharmafile | August 30, 2017 | News story | Research and Development, Sales and Marketing | Chagas disease, FDA, biotech, drugs, pharma, pharmaceutical
The FDA has announced that it has granted an accelerated approval for the use of benznidazole in children between the ages of 2 and 12 years old with Chagas disease. The treatment was brought in front of the FDA by the non-profit union of Drugs for Neglected Disease initiative (DNDi), Chemo Group and Mundo Sano.
As part of this union, the pharma part of the collaboration, Chemo Group, has vowed to sell the treatment at cost value, ‘plus a reasonable margin’. Being awarded a Tropical Disease Priority Review Voucher also means that the union could receive windfall of $100 million and above. In the press release regarding the union, the organisations had revealed that 50% of the value of the voucher would go into Mundo Sano’s non-profit activities.
The decision to approve the treatment was based on two clinical trials where children between six and 12 years old were treated with benznidazole. The results showed that 60% and 55% of children who received treatment tested negative for the disease after treatment, compared with 14% and 5% of children receiving the placebo across the two trials.
There are approximately 300,000 suffering from Chagas disease in the US. It is a potentially life-threatening condition caused by the Trypansosoma cruzi parasite and it often does not show any sign of infection, meaning it is sometimes referred to as the ‘silent killer’. It is particularly prevalent in Latin American countries, where it is endemic.
“Our ambition is to put an end to a scandalous and unjustifiable situation where almost none of the people living with Chagas have access to existing treatments,” said Dr Bernard Pécoul, DNDi Executive Director. “Registering benznidazole with the FDA will allow us to overcome the difficulties US patients have in accessing the drug, and will facilitate the registration process for the rest of the Americas.”
The latter point is part of the collaboration’s overall plan to improve access, as an FDA approval is regarded as a watermark for wider national regulatory bodies.
Ben Hargreaves
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