FDA Grants Fast Track Status to Drug Being Studied for Lupus Treatment

The U.S. Food and Drug Administration (FDA) announced that it has granted a Fast Track designation to Eli Lilly and Co. for its investigational drug, baricitinib, which is being studied for the treatment of systemic lupus erythematosus (SLE). The drug saw positive results from a Phase 2 study.

Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

In the United States, all drugs must undergo an approval process by the FDA. From initial formulating to FDA approval, most drugs take approximately 10 years before becoming available to consumers. There are five phases of drug development – Phase I: Discovery & Development (compound exploration and experimentation), Phase II: Preclinical Research (testing), Phase III: Clinical Research, Phase IV: FDA Review, and Phase V: FDA Post-Market Safety Monitoring (drug advertising and compliance regulation).

Once a drug has passed clinical trials, it moves on to Phase IV FDA Review and the pharmaceutical company files a New Drug Application to market the drug. The FDA reviews the application and clinical study findings, usually a 6 to 10-month process. The Fast Track designation will expedite the review process, with early and frequent communication between the FDA and, in this case, Eli Lilly.

Lupus research is improving day-to-day. The Lupus Foundation of America will continue to monitor and report on the progress of baricitinib.