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.
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