Eli Lilly and Co. (NYSE:LLY) on Friday shared new results from Ebglyss (lebrikizumab-lbkz) for moderate-to-severe atopic dermatitis.
Ebglyss showed sustained similar levels of skin clearance when administered as a single injection of 250 mg once every eight weeks (Q8W) compared with once every four weeks (Q4W).
The data support a potential additional, less frequent maintenance dosing option for more individualized treatment.
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Data
These data support that once every eight-week Ebglyss dosing could give a new treatment option using the lowest effective dose.
In the ADjoin extension study, results indicate that maintenance dosing every other month demonstrated similarly high rates of disease control compared to monthly dosing:
- 79% of patients taking Ebglyss once every other month and 86% of patients taking EBGLYSS monthly, respectively, achieved or maintained EASI 75.
- 62% of patients taking EBGLYSS once every other month and 73% of patients taking EBGLYSS monthly, respectively, achieved or maintained IGA 0,1.
- There was no increased risk of immunogenicity (the production of anti-drug antibodies), and no new safety findings.
Lilly has submitted these data from the ADjoin extension trial, among other data, to the FDA for a potential label update.
A study investigating Ebglyss maintenance dosing of 500 mg administered once every 12 weeks (Q12W) is underway.
Eli Lilly and its partner, Incyte Corporation (NASDAQ:INCY), shared new data from oral baricitinib 4 mg.
At one year:
- 54.1% of patients receiving baricitinib 4 mg and 31% receiving baricitinib 2 mg achieved successful hair regrowth.
- 41.2% of patients receiving baricitinib 4 mg and 26.2% receiving baricitinib 2 mg achieved near-complete scalp hair regrowth.
- 64.8% of patients receiving baricitinib 4 mg and 27.8% receiving baricitinib 2 mg achieved significant eyebrow regrowth.
- 63.3% of patients receiving baricitinib 4 mg and 34% receiving baricitinib 2 mg achieved eyelash regrowth.
- Among patients with severe disease, 71% receiving baricitinib 4 mg and 58.6% receiving baricitinib 2 mg achieved successful hair regrowth.
In a separate, post-hoc analysis of adolescent patients diagnosed with severe AA less than two years before starting treatment, 80% of those receiving baricitinib 4 mg and 64.3% receiving baricitinib 2 mg achieved successful hair regrowth at one year.
Among adults with severe AA who responded to baricitinib at 52 weeks, 86.5% of patients receiving baricitinib 4 mg and 84.7% of patients receiving baricitinib 2 mg achieved sustained scalp hair regrowth through approximately four years of treatment.
Lilly intends to submit the adolescent data to global regulators for a potential label update for Olumiant, and plans to enroll the next cohort of children ages 6 to under 12 in the U.S. to BRAVE-AA-PEDS next year.
Price Action: LLY stock is up 1.40% at $832.51 at the last check on Friday.
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