This Will be the First NCE (New Chemical Entity) Launch by an Indian Company Across Multiple Geographies
Glenmark Pharmaceuticals Limited announced today that the US Food and Drug Administration has provided Marketing approval to its partner in US, Salix Pharmaceuticals Limited, 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).
"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. Most importantly, this is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience non-infectious diarrhea, which often can lead to reduced treatment compliance. This will also help us accelerate filing across countries and also propel our development in additional diarrhea indications including the acute indications," said Glenn Saldanha , Chairman & MD, Glenmark Pharmaceuticals Limited.
He added, "Crofelemer, a locally-acting, minimally-absorbed drug is believed to act by blocking chloride secretion and thus reducing the accompanying high volume water loss seen in HIV associated diarrhea. It is this secretion that is believed to lead to diarrhea with the associated symptoms of dehydration, electrolyte imbalance, abdominal cramping, urgency and increased frequency. 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."