FDA Grants Fast Track Status to Telitacicept for Lupus Treatment
Telitacicept, an investigational drug by RemeGen, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) as a possible treatment for lupus. With its novel dual-target mechanism, telitacicept has shown to effectively reduce disease activity and is well tolerated in people with lupus in combination with standard therapy. Fast Track status allows the FDA to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need. The purpose is to potentially get important new drugs to patients earlier.
Telitacicept inhibits the development and survival of specific types of B cells, certain types of white blood cells implicated in several autoimmune diseases like lupus. At the same time, it also spares early and memory B cells, which are important to protect for normal immune system function. In its latest phase 2b trial, the drug was found to be safe and effective. About 75% of study participants receiving the treatment achieved clinically meaningful disease activity improvements compared to about 33% of people in the placebo group.
Although lupus is estimated to affect as many as 1.5 million people in the United States, there are relatively limited treatment options for this complex disease. Telitacicept shows promise for future approval as a lupus drug, and its newly designated Fast Track status can help get the medication into the hands of people who need it sooner rather than later. The Lupus Foundation of America has been closely monitoring telitacicept news since reporting on the drug’s initial trial success shared at the Annual College of Rheumatology Annual Scientific Meeting last fall.
Continue to follow the Lupus Foundation of America for telitacicept updates, as well as other lupus drug development news, and learn about medications used to treat lupus.