Sanofi Received U.S. FDA Approval of Fexinidazole Treatment

The United States Food and Drug Administration has finally granted approval to Sanofi’s new drug named Fexinidazole for the treatment of sleeping sickness. It is expected to be the very first all-oral treatment displaying state-of-the-art drug technology.

U.S. FDA has provided a boost to the implementation of Fexinidazole for treating both the stages of the commonly known sleeping sickness referred to as Trypanosoma brucei gambiense. The drug will be delivered to patients with an age 6 years and above with minimal weight requirement of 20kg. The drug development targeting Fexinidazole was commenced as a part of a fruitful partnership of the company with a non-profit organization heavily invested in initiating research and development activities.

Drugs for Neglected Diseases initiative (DNDi) was the non-profit partner enabling research. It was the epicentre of clinical trials that explained the utility of this treatment. The clinical trials conducted by DNDi were in collaboration with two other candidates first, the National Sickness Programs of the Democratic Republic of Congo (DRC) along with Central African Republic (CAR), and Sanofi.

Sleeping sickness is a highly infectious disease often misjudged by its name as a common disease. It is parasitic in origin and easily transmitted when bitten by an infected tse-tse fly. The disease has been highly prevalent across remotely housed rural areas across sub-Saharan Africa. These areas are observed to pose about 65 million people to the risk of contraction.With the initiatives of Sanofi encouraged by the other partners, the sleeping sickness cases reported to WHO have reduced significantly by nearly 97% from 2001 to 2020.