FDA approval expands EBGLYSS maintenance dosing to once every eight weeks, offering fewer injections for patients with moderate-to-severe atopic dermatitis.
- The updated dosing option reduces treatment frequency to as few as six injections per year, compared to the previous once-monthly regimen.
- The approval is supported by Phase 3 ADjoin extension data, which evaluated both four-week and eight-week dosing over a 32-week period.
- Safety findings remained consistent, with no new safety signals or treatment discontinuations reported during the study period.
Eli Lilly and Company (LLY) said on Tuesday that the U.S. Food and Drug Administration (FDA) has approved a new maintenance dosing option for Ebglyss, allowing one injection every eight weeks for certain patients with moderate-to-severe atopic dermatitis aged 12 and older.
The drug was previously approved for a once-monthly maintenance dose, but the latest update now gives patients the option to reduce treatment frequency to as few as six injections per year.
Shares of LLY ended the regular session on Tuesday down 0.39% before extending losses in after-hours trading. At the time of writing, LLY was trading down 0.23%.
Backed By Long-Term Clinical Data
The approval is supported by exposure-response modeling and data from the Phase 3 ADjoin long-term study extension, which evaluated every-four-week and every-eight-week maintenance dosing over a 32-week period.
Lilly said no new safety signals were identified during the extension study, and no patients discontinued treatment due to adverse events over the 32 weeks.
Medical experts involved in the ADjoin study said the extended dosing option offers a more flexible approach for patients managing chronic symptoms.
Patient advocates also highlighted the potential benefit of fewer injections, pointing to reduced treatment burden and fewer disruptions from ongoing disease management.
“Today’s approval builds on Ebglyss’ established long-term durability, with a new option for one maintenance dose every eight weeks. For people living with moderate-to-severe atopic dermatitis, that means a treatment they only need to take as few as six times a year—without prescription topicals from the start,” said Adrienne Brown, executive vice president and president of Lilly Immunology.
Lilly holds exclusive rights to Ebglyss in the U.S. and most global markets outside Europe.
LLY Stock: What Retail Thinks
On Stocktwits, retail sentiment around LLY stock is ‘bullish,’ unchanged over the past 24 hours, while message volume is ‘high.’
The watcher count for LLY increased by 1.7% over the past month, while message volume jumped by 580% during the same period.
The LLY stock has gained over 48% in the past 12 months.
For updates and corrections, email newsroom[at]stocktwits[dot]com.<
