Eli Lilly’s EBGLYSS Gets FDA Nod for Every-8-Week Dosing
Eli Lilly (LLY) received FDA approval for an expanded maintenance dosing regimen for EBGLYSS (lebrikizumab-lbkz), allowing injections every eight weeks for patients with moderate-to-severe atopic dermatitis. This reduces the annual number of injections to six.
Key Numbers
Eli Lilly (LLY) announced that the U.S. Food and Drug Administration (FDA) has approved a new dosing schedule for EBGLYSS (lebrikizumab-lbkz) for the treatment of moderate-to-severe atopic dermatitis. The decision allows maintenance dosing once every eight weeks, cutting the number of annual injections to just six.
The Product
EBGLYSS is a monoclonal antibody that targets IL-13, a key inflammatory pathway in atopic dermatitis. It was initially approved in September 2023 with a loading dose followed by maintenance every four weeks. The new schedule reduces injection frequency by 50%.
Pricing and Availability
Eli Lilly has not announced any change in the drug's price. EBGLYSS is available by prescription and administered via subcutaneous injection.
Competition
EBGLYSS competes with other biologics such as Dupixent (Sanofi/Regeneron) and Adbry (Leo Pharma). The less frequent dosing schedule gives it a competitive advantage in the market.
Potential Impact on the Company
The new dosing regimen is expected to improve patient adherence and expand the user base, potentially boosting EBGLYSS revenues. This is a positive development for Eli Lilly in the dermatology biologics market.
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