Eli Lilly and Company (LLY) has received a significant boost with the FDA’s approval of its IL-13 inhibitor, Ebglyss (lebrikizumab), for the treatment of moderate-to-severe atopic dermatitis, also known as eczema. This approval marks a key milestone for Lilly, as Ebglyss is now available for use in adults and children aged 12 and above who weigh at least 40 kgs and whose eczema is not adequately controlled with topical prescription medications.
Ebglyss had already gained approval in the European Union in 2023 and in Japan earlier this year. Despite being relatively new to the market, Ebglyss generated $7.5 million in sales during the first half of 2024. This new treatment option is expected to contribute significantly to Lilly’s overall revenue in the coming months and years.
This approval comes at a time when Lilly is experiencing remarkable success with its new drug launches. The company’s stock price has soared 58.5% year-to-date, significantly outperforming the industry growth of 25.2% and even surpassing the sector and the S&P 500. This strong performance is largely attributed to the success of Lilly’s new drugs, particularly Mounjaro and Zepbound.
The approval of Ebglyss was based on data from three clinical trials, ADvocate 1, ADvocate 2, and ADhere, which demonstrated significant skin clearance as early as four weeks and substantial itch relief within just two weeks for patients treated with Ebglyss. For many individuals living with eczema, long-term disease control and severe itch remain persistent challenges despite topical treatment. Ebglyss provides a new, first-line biologic treatment option for these patients, offering hope for improved quality of life. The injection will be launched in the United States in the coming weeks.
In the United States and other countries outside of Europe, Lilly retains exclusive rights to develop and commercialize Ebglyss. However, in Europe, Lilly has partnered with Almirall to develop and market Ebglyss for dermatological indications.
Beyond Ebglyss, Lilly has achieved a remarkable string of new drug approvals in the past year. Mounjaro and Zepbound, both incorporating the same compound, tirzepatide, a dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA), have made significant contributions to Lilly’s financial performance. Mounjaro, approved in May 2022 for type II diabetes, and Zepbound, launched in November 2023 for obesity, have generated almost $6.7 billion in sales during the first half of 2024, accounting for around 44% of the company’s total revenues.
Other notable new drug approvals include Omvoh for ulcerative colitis and Jaypirca, a BTK inhibitor, for mantle cell lymphoma and chronic lymphocytic leukemia. Lilly anticipates that these new drugs, including Mounjaro, Omvoh, Zepbound, Ebglyss, and Jaypirca, will continue to drive strong top-line performance in the second half of 2024.
In a further testament to Lilly’s commitment to innovation, the company secured FDA approval for Kisunla (donanemab) in July, marking a significant breakthrough in the treatment of early symptomatic Alzheimer’s disease. Lilly is confident that Kisunla has the potential to achieve blockbuster sales, becoming only the second drug on the market to treat Alzheimer’s disease after Biogen’s Leqembi, developed in partnership with Eisai.
Lilly’s strong financial performance and commitment to innovation have garnered recognition, with the company earning a Zacks Rank #1 (Strong Buy). Analysts are optimistic about Lilly’s future prospects, and the company continues to be a leader in the pharmaceutical industry.
Other leading drugmakers, such as Novartis (NVS) and Pfizer (PFE), also hold strong positions in the market, both receiving a Zacks Rank #2 (Buy). Pfizer’s earnings estimates have been consistently increasing, and the company has delivered strong earnings surprises in recent quarters. Novartis has also seen its earnings estimates rise, with a consistent track record of exceeding earnings expectations. Both companies are expected to continue their growth trajectories in the pharmaceutical sector.
