Lebrikizumab Wins FDA Approval for Eczema

The FDA approved lebrikizumab (Ebglyss) for treating atopic dermatitis in adults and children ages 12 years and up, drugmaker Eli Lilly announced on Friday.

Approval of the injectable interleukin (IL)-13 inhibitor stipulates use with or without topical corticosteroids for patients with moderate-to-severe cases of the chronic skin condition that is not well controlled despite use of topical prescription drugs.

Support for the indication came from the phase III ADvocate 1, ADvocate 2, and ADhere trials, which together included more than 1,000 patients with moderate-to-severe eczema.

Pooled data from the ADvocate trials showed that 38% of lebrikizumab-treated patients achieved an Investigator Global Assessment (IGA) score of 0 or 1 (indicating clear or almost-clear skin) at 16 weeks, as compared with 12% of placebo recipients.

In those achieving an IGA score of 0-1 at 16 weeks, 77% maintained that level of response at 1 year using monthly maintenance therapy as compared with 48% of the responders who stopped therapy.

“Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives,” said investigator Jonathan Silverberg, MD, PhD, MPH, of George Washington University School of Medicine and Health Sciences in Washington, D.C., in a statement. “Today’s FDA approval of Ebglyss is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren’t enough.”

Other data from ADvocate 1 and ADvocate 2 showed higher proportions of itch relief among the lebrikizumab groups (43% vs 12% in the placebo groups at week 16). The vast majority of responders maintained itch relief out to a year with maintenance dosing: 85% versus 66% for those who stopped treatment after 16 weeks.

According to the prescribing information, common adverse events in the trials included eye and eyelid inflammation, injection site reactions, and shingles. The warnings and precautions in the labeling also has notes about hypersensitivity reactions, conjunctivitis and keratitis, parasitic infections, and vaccination while on treatment.

Lilly said it expects lebrikizumab to be available to the U.S. market in the coming weeks.

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