Potential Treatment for Lupus is Granted Fast Track Designation From the FDA

According to a story from BioSpace, Incyte Corporation and Eli Lilly and Company recently announced that the US Food and Drug Administration (FDA) has given the drug baricitinib Fast Track designation as a treatment for systemic lupus erythematosus (SLE). Previous clinical data has suggested that baricitinib could be a useful therapy for this disease.

About Systemic Lupus Erythematosus

Systemic lupus erythematosus, more commonly known simply as lupus, is an autoimmune disease that is characterized by a red facial rash. An autoimmune illness is one in which the body’s own immune system begins to damage healthy tissue. Certain drugs can induce the disease, but it most commonly caused by a combination of certain genetic variants, which, when exposed to an environmental trigger, can cause symptoms to begin. Symptoms of lupus include facial rash, swollen, painful joints, fatigue, fever, swollen lymph nodes, chest pain, hair loss, and mouth ulcers. Women are more frequently affected than men. The disease tends to appear in a relapsing-remitting pattern of symptoms. Its symptoms are often vague at first, making diagnosis of lupus more difficult. Treatment may include avoiding sunlight, immune system suppressing drugs, and pain medication. Most people with lupus are able to control their disease effectively without overall lifespan being affected. To learn more about systemic lupus erythematosus, click here.

A New Breakthrough?

It has been many years since any new therapies have been introduced for treating lupus. Baricitinib is already approved for public use as a treatment for patients with rheumatoid arthritis who have failed to respond well to tumor necrosis factor antagonist drugs. Continued testing of the drug for lupus is ongoing in a Phase 3 clinical trial. Baricitinib is also being tested as a treatment for severe atopic dermatitis

About Fast Track Designation

Fast Track designation is reserved for therapies that demonstrate the potential to treat serious medical conditions or fulfill a currently unmet medical need. Alternatively, the drug most display advantages in safety or effectiveness in comparison to currently available therapies. When a drug receives Fast Track designation, the developer will be able to meet and communicate more frequently with the FDA in order to facilitate the successful development of the drug. Fast Track approval can also qualify a therapy for Accelerated Approval, Priority Review, and Rolling Review if all other qualification requirements are met for them.


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