American pharmaceutical company Eli Lilly's new drug for eczema is all set to hit the market after it received green signal from the U.S. Food and Drug Administration (FDA) to treat eczema in adults and children above 12 years.
The drug ebglyss (lebrikizumab-lbkz), which is administered through an injection, can provide itch relief in two weeks and clear the skin in one month, Eli Lilly said. The drug works by targeting IL-13, a protein linked to eczema.
The company added that it is expecting to launch the drugin US in the coming weeks.
The regulatory body gave approvalafter analyzing data from three studies involving more than 1,000 adults and children affected with eczema. All the participants in the study had moderate-to-severe cases of eczema(atopic dermatitis), symptoms of which were untreatable with topical prescription medicines.
During the four-month study period, patients received 500 mg doses of ebglyssinitially and 250 mg of ebglyss or placebo every two weeks until the end. They also received a maintenance dose of 250 mg every two weeks or four weeks after the first four months for thenext 36 weeks.
In a month after starting the treatment, 10 percent of the participants achieved a clear or almost clear skin and about 38 percent of the participants achieved the same in four months. With a monthly dose of ebglyss, about 77 percent of the participants maintained a clear skin for one year. Interestingly, about 48 percent of the participants who changed to a placebo at four months also succeeded in maintaining a clear skin for almost a year.
Eli Lilly's new drug for eczema brings hopes to millions of people affected with eczema, experts said.
"The approval of EBGLYSS provides hope and promise for the eczema community and those still seeking lasting relief from disruptive symptoms." Kristin Belleson, President and CEO of the National Eczema Association, said.
According to the National Eczema Association, nearly 16.5 million adults and more than 9.6 million children in the U.S. have eczema.The skin condition presently doesn't have a permanent cure but can be controlled to a limit by making changes in lifestyle or through certain medications.
"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," first author of the study, Jonathan Silverberg, professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, DC, said 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," he noted.
Ebglyss is already used in Japan and Europe for treating eczema since 2023 and 2024 respectively.