Fast Track may put new drugs on the market quicker

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Posted: Wednesday, October 30, 2013 5:09 pm

ORLANDO, Fla. (Ivanhoe Newswire) -- Speeding the development and availability of drugs that treat serious diseases are in everyone’s interest, especially when the drugs are the first available treatment. The FDA developed a distinct approach to make sure these drugs are available as soon as possible, called fast track.

Researchers are on the fast track to develop a drug that could reverse fibrosis and cirrhosis in the kidneys, lungs, and liver of patients who have NASH—non-alcoholic steatohepatitis—more commonly known as fatty liver disease.

Researchers say that currently there is not a FDA approved drug for fibrosis, so the potential is huge.

NASH affects between 9 to 15 million Americans. Over time, patients can develop fibrosis and about three million will develop cirrhosis. The phase 1 clinical trial will enroll patients at six clinical sites in the U.S.

Another potential breakthrough receiving fast track status is a treatment to improve overall survival in patients with metastatic non-small cell lung adenocarcinoma, who have progressed following one chemotherapy regimen.

The drug would be administered in combination with docetaxel. Lung cancer is the leading cause of cancer-related deaths in the world. Non-small cell adenocarcinoma accounts for 40 percent of all lung cancers. It is being evaluated in over 20 clinical trials.

By the way, in 2012 the FDA granted fast track status to 22 drugs. To learn more about the program, go to http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122932.htm.

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