INDIANAPOLIS - Eli Lilly and Company (NYSE: NYSE:LLY) announced the FDA approval of its new biologic treatment, EBGLYSS™ (lebrikizumab-lbkz), for patients 12 years and older with moderate-to-severe atopic dermatitis (eczema) not well managed by topical prescriptions. The approval is based on results from three clinical studies, including over 1,000 adults and children, showing significant skin clearance and itch relief.
EBGLYSS, a targeted IL-13 inhibitor, is administered initially as two 250 mg injections at the start and again at two weeks, followed by 250 mg every two weeks until Week 16. Patients who achieve an adequate clinical response then switch to a monthly maintenance dose. The treatment can be used with or without topical corticosteroids.
Clinical trials reported 38% of EBGLYSS-treated patients achieving clear or almost clear skin at 16 weeks, with some seeing results as early as four weeks. For itch relief, 43% of patients felt improvement at 16 weeks, and some as early as two weeks. Additionally, 77% of patients who had clear skin and 85% who experienced itch relief at 16 weeks maintained these results through one year with monthly dosing.
Common side effects include eye and eyelid inflammation, injection site reactions, and shingles. EBGLYSS is not suitable for individuals allergic to its active ingredient or any of its components.
Eli Lilly has emphasized its commitment to making EBGLYSS accessible, including a patient support program with co-pay assistance for eligible patients.
EBGLYSS was previously approved by the European Commission in 2023 and in Japan in January 2024. Eli Lilly holds exclusive rights for EBGLYSS's development and commercialization in the U.S. and globally, except Europe, where Almirall S.A. has the rights.
This news is based on a press release statement from Eli Lilly and Company.
In other recent news, Eli Lilly has been making significant strides in its operations. The pharmaceutical giant has announced successful Phase III trial results for its once-weekly insulin efsitora, showing A1C reduction non-inferior to daily basal insulins. The company has also revealed a $1.8 billion investment to expand its manufacturing facilities in Europe, a strategic move to bolster the production of biologic active ingredients and navigate the complexities of the pharmaceutical market.
Eli Lilly has appointed Lucas Montarce as its new Chief Financial Officer, a development that is part of the company's ongoing strategic planning. The company has also entered into a collaboration with EVA Pharma to increase the availability of baricitinib, an immunological treatment, in 49 African countries. Furthermore, Eli Lilly has completed the acquisition of Morphic Holding (NASDAQ:MORF), Inc., adding a therapy for inflammatory bowel disease to its portfolio.
Various firms have maintained positive ratings on Eli Lilly's shares. BMO Capital maintained its Outperform rating, reflecting confidence in Eli Lilly's growth trajectory, while TD Cowen reaffirmed a Buy rating. However, Evercore ISI maintained an In Line rating. These are recent developments from Eli Lilly.
InvestingPro Insights
Eli Lilly's recent FDA approval of EBGLYSS™ marks a significant milestone for the company and its stakeholders. This achievement reflects the company's strong position within the pharmaceutical industry, a status underscored by its impressive financial performance. InvestingPro data shows a robust revenue growth of 31.87% in the last twelve months as of Q2 2024, indicative of the company's ability to innovate and expand its product portfolio successfully.
InvestingPro Tips highlight Eli Lilly's consistent financial discipline and growth potential. The company has notably raised its dividend for 9 consecutive years, showcasing a commitment to returning value to shareholders. Additionally, analysts have revised their earnings upwards for the upcoming period, signaling confidence in Eli Lilly's future financial performance.
Investors considering Eli Lilly should note its high P/E ratio of 113.35, which suggests the market has high expectations for the company's earnings potential. This, coupled with the fact that the company is trading near its 52-week high, indicates strong investor sentiment. Eli Lilly's commitment to innovation in treatments like EBGLYSS™ may continue to drive this positive outlook.
For those seeking a more in-depth analysis, InvestingPro offers additional tips on Eli Lilly, including insights into its valuation multiples, profitability, and debt management. There are 19 more InvestingPro Tips available, providing a comprehensive understanding of the company's financial health and investment potential.
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