FDA Fast Track

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.



BACKGROUND: Fast track is a new process that is created to speed the course of drug review. This was designed so patients with serious illness can receive their drugs at a quicker rate. This process will help patients who are in need of their medications to survive or to function. Heart failure, AIDS, cancer and Alzheimer's are all diseases that Fast Track will work with because it is imperative that these patients receive their medication and treatment. Other illnesses and conditions are considered for the process as well, like diabetes, epilepsy and depression. This process must be requested by the drug company and approved by the FDA before medication is administered, but this will cut the wait time for prescription drugs and keep patients more comfortable and satisfied. (Source: http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm)


NONALCOHOLIC STEATOHEPATITIS: Galectin Therapeutics was recently approved by the FDA to release GR-MD-02 to Fast Track. GR-MD-02 is a complex carbohydrate drug that focuses on the galectin-3 protein to reverse liver, kidney and lung cirrhosis. This drug is targeted towards patients who suffer from NASH, nonalcoholic steatohepatitis with advanced fibrosis. This "silent" liver disease affects two to five percent of Americans and is becoming more common due to the growth in obesity. Gelactin Therapeutics conducted a clinical trial on patients with NASH consisting of four weekly doses of GR-MD-02. Forty volunteers at six different clinical sites in the U.S. participated in the study to measure the tolerability and safety of the product. Below is a list of locations that hosted the study:

·         The Mount Sinai Medical Center (Division of Liver Diseases)

·         Emory University Hospital (Transplant Center Clinical Research)

·         Indiana University School of Medicine

·         Virginia Commonwealth University Medical Center

·         Brooke Army Medical Center

·         St. Louis University School of Medicine

(Source: http://digestive.niddk.nih.gov/ddiseases/pubs/nash/ and http://phx.corporate-ir.net/phoenix.zhtml?c=135403&p=irol-newsArticle&ID=1846800&highlight)


METASTATIC NON-SMALL CELL LUNG ADENOCARCINOMA: Lung cancer is the leading cause of cancer deaths in the U.S. in both men and women. However, it is one of the most preventable cancers if detected in early stages. Synta Pharmaceuticals released a drug to stop cancer cell processes. Synta held more than 20 clinical trials with over 700 patients for the product to evaluate the effects on patients. The clinical trial is still ongoing but is not recruiting volunteers. Here are the locations where the trial was studied:


·         Tucson, Arizona

·         Boston, Massachusetts

·         Santa Monica, California

·         Winston-Salem, North Carolina

·         Atlanta, Georgia

·         Kettering, Ohio

·         Chicago, Illinois

·         Portland, Oregon


·         Canada

·         Russian Federation

·         Croatia

·         Serbia

·         Czech Republic

·         Spain

·         Poland

·         United Kingdom

·         Romania

·         Germany

(Source: http://www.mayoclinic.org/lung-cancer/ and http://www.syntapharma.com/pipeline-ganetespib.php)