FDA Grants Fast Track Status to Telitacicept for SLE
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The FDA granted fast track designation to the recombinant fusion protein RC18 for the treatment of systemic lupus erythematosus, according to the drug’s manufacturer.
RC18 (telitacicept, RemeGen) is a novel recombinant transmembrane activator and calcium modulator and cyclophilin ligand interactor fusion protein that operates by targeting and neutralizing B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). Given this drug mechanism, RemeGen is currently evaluating its use for other autoimmune diseases, such as rheumatoid arthritis and multiple sclerosis.
“SLE is a chronic autoimmune disease which attacks healthy tissue,” Jianmin Fang, PhD, founder and CEO of RemeGen, said in a press release. “With no cure, SLE is estimated to affect between 322,000 and 1.5 million people in the U.S. With limited treatment options available for patients, the fast track designation gives RemeGen the opportunity to help those impacted by offering a therapy with first-in-class and best-in-class potential.”
The FDA based its decision on efficacy and safety results from a phase 2b, double-blind, placebo-controlled study of telitacicept among patients with SLE receiving standard therapy (n = 249), which was presented at the 2019 annual meeting of the American College of Rheumatology. Investigators randomly assigned patients to receive either placebo or subcutaneous telitacicept in doses of 80 mg, 160 mg or 240 mg once weekly.
According to study results, 75.8% of patients in the 240-mg group achieved clinically meaningful disease activity improvement (P < .001), compared with 33.9% in the placebo cohort. Further, more patients reported a reduction of at least 4 points in SELENA-SLEDAI score at week 48 with telitacicept 80 mg (75.8%, P = .003), 160 mg (77.8%, P = .001) and 240 mg (79%, P < .001) than with placebo (50%).
According to researchers, the most common adverse events associated with telitacicept were upper respiratory tract infections and injection site reactions; one death was reported in the telitacicept 240-mg group, but was not considered related to the drug.
“We are very pleased with the fact that over 70% of patients who were treated with RC18 showed clinically meaningful benefit in this trial,” lead investigator Di Wu, MD, PhD, from the department of rheumatology at Peking Union Medical College Hospital, said in a press release. “This is the latest chapter in the very promising treatment story of RC18, and we are excited about making this treatment a reality and available to the many who are impacted by lupus daily.”
The FDA provides fast track status to facilitate the development of new products for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs, with the goal of getting important new products to patients earlier. Fast track status will also allow the company to work closely with the FDA to expedite the review of aspects of telitacicept to improve the efficiency of product development.