FDA News Release (12.31.12)
Aids Weekly Plus
On December 31, the US Food and Drug Administration approved Fulyzaq (Crofelemer) to treat diarrhea symptoms in HIV/AIDS patients currently on antiretroviral therapy (ART). Many ART patients either change or discontinue their therapies because of the resultant diarrhea. Fulyzaq is intended for HIV/AIDS patients whose diarrhea is not caused by infection from a virus, bacteria, or parasite. Derived from the red sap of the Croton lechleri plant, Fulyzaq is only the second botanical prescription drug approved by the FDA—a botanical drug can be a complex mixture derived from one or more plant materials of varying degrees of purity. Currently, there are no other FDA-approved therapies for HIV-associated diarrhea, according to Julie Beitz, MD, director of the Office of Drug Evaluation III in FDA’s Center for Drug Evaluation and Research.