FDA Guidance Addresses Development of Lupus Drugs
Describing the current treatments for systemic lupus erythematosus (SLE) as inadequate, a new FDA document aims to help industry develop new treatments for the immune system disease.
In a draft guidance released March 28, the FDA offered recommendations on the measurement of lupus disease activity and clinical outcomes; reduction in disease activity and flares; treatment of organ-specific disease; trial design issues and analysis; surrogate markers as endpoints; and risk-benefit assessment.
Recent improvements in care have dramatically enhanced the survival of SLE patients with the most severe and life-threatening manifestations, the guidance said. "Unfortunately, current treatments for SLE remain inadequate as many patients have incompletely controlled the disease, progression to end-stage organ involvement continues, and current therapies carry potential risks of debilitating side effects," the guidance says.
The FDA may be willing to approve a number of claims for new drug therapies for SLE if supported by substantial evidence, according to the guidance. The claims identified in the guidance include: 1) reduction in disease activity; 2) treatment of lupus involving a specifically identified organ, such as the kidney; 3) complete clinical response/remission; and 4) reduction in flares.
To view the FDA draft guidance, "Systemic Lupus Erythematosus -- Development Drugs For Treatment," published in the March 29 Federal Register, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/2005d-0106-gdl0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/2005d-0106-gdl0001.pdf).