Glenmark Pharmaceuticals - partner in US - Salix Pharmaceuticals, has received marketing approval from US Food and Drug Administration (USFDA) for Crofelemer 125 mg delayed-release tablets for the symptomatic relief of non-infectious diarrhea in patients with human immunodeficiency virus (HIV) / acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART).
Crofelemer is believed to improve HIV associated diarrhea via dual mechanisms of action with inhibition of both CFTR (Cystic Fibrosis Transmembrane Conductance Regulator Protein) and CaCC (calcium-activated chloride channel) resulting in reduced chloride ion secretion into the GI lumen.
Besides, the USFDA approval of Crofelemer for HIV associated diarrhea will pave the wave to launch Crofelemer across our territories. This is a significant approval milestone and will enable the first NCE launch by Glenmark across emerging markets.
