Responding to FDA Approval of Lebrikizumab for Atopic Dermatitis, with Andrew Alexis, MD, MPH

After the notable approval by the US Food and Drug Administration (FDA) of lebrikizumab-lbkz (Ebglyss) for adults and children aged 12 years or older with moderate-to-severe atopic dermatitis in early September, the HCPLive team spoke with Andrew F. Alexis, MD, MPH, about the FDA decision’s significance.^1,2

Alexis works as a professor of clinical dermatology at Weill Cornell Medicine. He touched on some of the data that preceded the approval of this targeted interleukin (IL)-13 inhibitor, noting that the move led to a significant addition to the drug armamentarium.

“The recent approval of lebrikizumab, a biologic monoclonal antibody targeting IL-13, represents a very significant advance,” Alexis said. “In our treatment armamentarium for atopic dermatitis, it is now the third biologic to come to the market…In the phase 3 studies that led to its approval, significant proportions of patients treated with lebrikizumab achieved significant improvement in their eczema as measured by EZ and IGA at Week 16.”

Alexis highlighted the extension trial which he noted demonstrated the medication’s efficacy among patients for up to a year.

“This presents us with another safe and effective treatment option for our huge population of patients who suffer from moderate to severe atopic dermatitis,” he explained. “And now we can offer our patients more choice and carefully select options that are most aligned with their overall condition and goals.”

Alexis also noted the significance of the approval given the age range indicated for lebrikizumab utilization.

“Of course, it goes without saying that our pediatric and adolescent population has a very high burden of disease of atopic dermatitis,” Alexis said. “So to be able to offer another systemic therapy that's targeted, that doesn't require blood work and doesn't have a black box warning, these are all very advantageous and very favorable additional options to offer our patients.”

Later, Alexis was asked about the safety profile of the drug in these findings prior to the approval by FDA officials.

“I think overall, the safety profile of lebrikizumab is very favorable,” Alexis explained. “I could see this being a treatment option for a vast majority of my atopic dermatitis patients who are moderate to severe and not adequately controlled on topicals or are simply just not candidates for topical therapy, in order to achieve adequate control of their condition.”

For additional information on the approval, view the full interview posted above.

The quotes contained in this interview summary were edited for the purposes of clarity.

References

1. ^{Smith T. FDA Approves Lebrikizumab Treatment of Eczema Among Patients Aged 12 and Older. HCPLive. September 13, 2024. https://www.hcplive.com/view/fda-approves-lebrikizumab-treatment-eczema-among-patients-aged-12-and-older. Date accessed: September 26, 2024.}
2. ^{FDA Approves Lilly's EBGLYSS™ (lebrikizumab-lbkz) for Adults and Children 12 Years and Older with Moderate-to-Severe Atopic Dermatitis. September 13, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and. Date accessed: September 13, 2024.}