FDA News

FDA grants fast track status to baricitinib development for SLE

The FDA granted fast track designation to baricitinib for the treatment of systemic lupus erythematosus, according to the drug’s manufacturer.

Following phase 2 study results demonstrating that 4-mg doses of baricitinib (Olumiant, Eli Lilly) were associated with significant clinical improvements among patients with SLE, Eli Lilly has begun enrollment in a global phase 3 development program for lupus.

There are a limited number of currently approved treatment options,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, told Healio Rheumatology. “Based on the positive phase 2 results, we are optimistic about the prospect that baricitinib could represent an important advancement in addressing the unmet needs of patients who continue to experience the debilitating, progressive symptoms of SLE.”

Prior to this fast track designation, SLE has garnered only a single FDA-approved therapy — belimumab (Benlysta, GlaxoSmithKline) in 2011 — and only narrowly, as its multicenter phase 2 trial failed to meet its primary endpoints. Since then, roughly 20 trials of various therapies have achieved suboptimal results, hampered by the much-chronicled heterogeneity of SLE, which frequently makes it a moving target for both clinicians and researchers.

The FDA based its decision on efficacy and safety results from the phase 2, double-blind, placebo-controlled study of baricitinib among patients with SLE receiving standard therapy, which was presented at EULAR and published in The Lancet. Patients were randomly assigned to receive either placebo, once-daily 2-mg doses of baricitinib or once-daily 4-mg doses of baricitinib.

According to study results, 67% of patients in the 4-mg group achieved the SLE Disease Activity Index-2K response for arthritis or rash at week 24, compared with 53% in the placebo cohort (P < .05). In addition, the proportion of patients who achieved flare reduction, lupus low disease activity state and a tender joint count change from baseline was also significantly improved among patients treated with 4 mg of baricitinib, compared with placebo.

We are currently studying two doses of baricitinib in phase 3 SLE trials and, as part of the fast track designation, Lilly will work closely with the FDA to further explore baricitinib’s potential as a treatment that can provide meaningful improvements for people with SLE,” Mallbris told Healio Rheumatology.

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 baricitinib to improve the efficiency of product development.

Reference:
Wallace DJ, et al. Lancet. 2018;doi: 10.1016/S0140-6736(18)31363-1.

The FDA granted fast track designation to baricitinib for the treatment of systemic lupus erythematosus, according to the drug’s manufacturer.

Following phase 2 study results demonstrating that 4-mg doses of baricitinib (Olumiant, Eli Lilly) were associated with significant clinical improvements among patients with SLE, Eli Lilly has begun enrollment in a global phase 3 development program for lupus.

There are a limited number of currently approved treatment options,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, told Healio Rheumatology. “Based on the positive phase 2 results, we are optimistic about the prospect that baricitinib could represent an important advancement in addressing the unmet needs of patients who continue to experience the debilitating, progressive symptoms of SLE.”

Prior to this fast track designation, SLE has garnered only a single FDA-approved therapy — belimumab (Benlysta, GlaxoSmithKline) in 2011 — and only narrowly, as its multicenter phase 2 trial failed to meet its primary endpoints. Since then, roughly 20 trials of various therapies have achieved suboptimal results, hampered by the much-chronicled heterogeneity of SLE, which frequently makes it a moving target for both clinicians and researchers.

The FDA based its decision on efficacy and safety results from the phase 2, double-blind, placebo-controlled study of baricitinib among patients with SLE receiving standard therapy, which was presented at EULAR and published in The Lancet. Patients were randomly assigned to receive either placebo, once-daily 2-mg doses of baricitinib or once-daily 4-mg doses of baricitinib.

According to study results, 67% of patients in the 4-mg group achieved the SLE Disease Activity Index-2K response for arthritis or rash at week 24, compared with 53% in the placebo cohort (P < .05). In addition, the proportion of patients who achieved flare reduction, lupus low disease activity state and a tender joint count change from baseline was also significantly improved among patients treated with 4 mg of baricitinib, compared with placebo.

We are currently studying two doses of baricitinib in phase 3 SLE trials and, as part of the fast track designation, Lilly will work closely with the FDA to further explore baricitinib’s potential as a treatment that can provide meaningful improvements for people with SLE,” Mallbris told Healio Rheumatology.

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 baricitinib to improve the efficiency of product development.

Reference:
Wallace DJ, et al. Lancet. 2018;doi: 10.1016/S0140-6736(18)31363-1.