Eli Lilly and Company LLY and partner Incyte INCY announced that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency has adopted a positive opinion recommending approval of Olumiant (baricitinib) for treating atopic dermatitis (“AD”).
Notably, Olumiant 2 mg is approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor ("TNF") antagonist therapies.
The Committee has recommended the label expansion of rheumatoid arthritis drug, Olumiant, for the treatment of adult patients with moderate-to-severe AD who are candidates for systemic therapy.
The positive CHMP opinion was based on the results from the phase III BREEZE-AD clinical development program evaluating Olumiant as a potential treatment for AD, which includes four late-stage studies. These studies evaluated the drug as monotherapy or in combination with topical corticosteroids. Data from all studies showed that treatment with Olumiant led to at least 75% improvement in skin inflammation from baseline and a score of “clear or almost clear skin” in statistically significant proportion of patients.
The European Commission will review the CHMP recommendation and a decision is expected in the next one to two months.
A potential label expansion should boost the drug’s sales, which came in at $84.7 million in the first six months of 2020, reflecting growth of 54.3% year over year.
Lilly’s shares have rallied 17.3% so far this year compared with the industry’s growth of 1.8%.
In a separate press release, the company announced detailed data from the phase III study —monarchE — evaluating its cancer drug, Verzenio, in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) high risk early breast cancer. Data from the study showed that following two years of treatment with the drug in combination with standard adjuvant endocrine therapy (“ET”) the risk of breast cancer recurrence was cut by 25% compared to standard adjuvant ET alone. The data were presented at the European Society for Medical Oncology 2020 Virtual Congress and simultaneously published in the Journal of Clinical Oncology.
Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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