Benznidazole Approved for Chagas Disease
August 29, 2017 – The U.S. FDA has approved benznidazole, manufactured by Chemo Group, for the treatment of acute Chagas infection in children between the ages of two and 12 years old. It is the first drug to receive full approval for the treatment of Chagas disease, also known as American trypanosomiasis, in the United States. The disease is caused by Trypanosoma cruzi, a parasite transmitted through contact with triatomine bugs.
According the Centers for Disease Control and Prevention, an estimated 300,000 Americans have Chagas disease. The disease has two phases. During the first, acute phase, symptoms are similar to the flu and last for a few weeks following exposure. Left untreated, Chagas disease can become chronic. The chronic form is typically asymptomatic, and can last for decades, eventually resulting in serious heart or digestive problems for an estimated 30% or more of affected individuals. Patients can also be reinfected after they have received treatment.
The presence of Chagas disease can be confirmed via a blood test for antibodies to the T. cruzi parasite. Recommended dosing for benznidazole is based on body weight; patients must take benznidazole by mouth twice per day for 60 days.
Launch and pricing plans are not yet available. However, Chemo Group has announced that it has partnered with non-profit organizations to ensure that the drug is reasonably priced and distribution to areas of greatest need is prioritized. Chemo Group has also announced that part of the profits from sales of benznidazole will be used to develop other drugs for neglected conditions.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.