Following positive results from phase 2 of the NOBILITY study, the FDA has granted breakthrough therapy designation to Genentech’s Gazyva for lupus nephritis.
“The FDA’s decision is an important milestone in our over decade-long commitment to researching potential therapies for lupus and lupus nephritis,” Jay Garg, MD, group medical director in product development for immunology, infectious diseases and ophthalmology at Genentech, told Healio Nephrology/Rheumatology. “We’re looking forward to meeting with health authorities to discuss how best to bring this therapy to people with lupus nephritis, who currently have no FDA-approved medicines available.”
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