FDA News

FDA grants breakthrough therapy designation to obinutuzumab for lupus nephritis

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. “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.”

According to a press release, Gazyva (obinutuzumab) — currently used as a treatment for certain types of cancer — demonstrated superior efficacy in achieving complete renal response at 1 year (combined with standard of care: mycophenolate mofetil or mycophenolic acid and corticosteroids) compared with placebo plus standard of care.

Phase 2 of NOBILITY was a randomized, double-blind, multicenter study that enrolled 126 patients.

“New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in the release. “We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a phase 3 trial next year.”

Reference:
https://mailchi.mp/gene/genentech-press-release-september-17-2019?e=f8942f7e2f

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. “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.”

According to a press release, Gazyva (obinutuzumab) — currently used as a treatment for certain types of cancer — demonstrated superior efficacy in achieving complete renal response at 1 year (combined with standard of care: mycophenolate mofetil or mycophenolic acid and corticosteroids) compared with placebo plus standard of care.

Phase 2 of NOBILITY was a randomized, double-blind, multicenter study that enrolled 126 patients.

“New treatment options are needed for lupus nephritis, a potentially life-threatening inflammation of the kidneys that most commonly affects women,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in the release. “We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a phase 3 trial next year.”

Reference:
https://mailchi.mp/gene/genentech-press-release-september-17-2019?e=f8942f7e2f