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Glenmark Pharmaceuticals said that the US Food and Drug Administration has provided marketing approval to its partner in the US, Salix Pharmaceuticals Limited, for Crofelemer, which provides relief to patients with diarrhea HIV and AIDS on anti-retroviral therapy.
Glenmark has exclusive Crofelemer rights for diarrhea indications in 140 countries including India and the approval is expected to accelerate filing and launch preparations across its territories.
This will be the first new chemical entity (NCE) launch by an Indian company across multiple geographies. Glenmark is the sole API supplier globally for Crofelemer, excluding China.
``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,'' said Glenn Saldanha, Chairman, Glenmark Pharmaceuticals.
The ailment can lead to reduced treatment compliance. Crofelemer is a minimally-absorbed drug and is believed to act by blocking chloride secretion and thus reducing the accompanying high volume water loss seen in HIV associated diarrhea.
The most common adverse reactions in the trials have been found to be respiratory tract infection, bronchitis, cough, flatulence, and increased bilirubin.
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