Glenmark Pharmaceuticals and Salix Pharmaceuticals Inc have earned FDA approval for their new anti-diarrhea drug Crofelemer 125 mg. The drug is aimed specifically at HIV/AIDS patients who need to control diarrhea symptoms while on retrovirus drugs.
The U.S. approval of the drug could help pave a path for approval in other countries in the near future. Glenn Saldanha, Glenmark's Chairman, says it's a huge step:
"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 anti-retovirals 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."
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