Print this page    •   Back to Web version of article

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. You can find this article online by typing this address into your Web browser:
http://www.thebody.com/content/66276/fda-grants-priority-review-for-crofelemer.html

General Disclaimer: TheBody.com is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through TheBody.com should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.