FDA Grants Priority Review for Crofelemer

March 16, 2012

On February 8, 2012, the Food and Drug Administration granted a priority review to crofelemer, a potential treatment for HIV-associated diarrhea.

Crofelemer tablets aim to treat diarrhea in patients with HIV or AIDS who are on anti-retroviral therapy. Salix estimates that about 150,000 patients on this therapy experience episodic or chronic diarrhea, which can lead to weight loss and affect compliance with the treatment.

As the largest crofelemer trial site in the U.S., ACRIA is very pleased to see this decision from the FDA.  The quality of life issues and the impact of chronic diarrhea make this first-in-class drug extremely important for people with HIV around the world.  If the FDA priority review ends with approval, this drug could be life-changing for thousands.

Salix Pharmaceuticals Ltd. had submitted crofelemer to regulators for review in December. A priority review is given to drugs that may offer treatment advances or provide a treatment where no adequate therapy exists.

The FDA has set a June 5 target date for making its decision on whether to approve the drug.

This article was provided by AIDS Community Research Initiative of America. Visit ACRIA's website to find out more about their activities, publications and services.

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