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Lilly's Olumiant Meets Primary Goal in Dermatitis Study

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Eli Lilly and Company (LLY - Free Report) and partner Incyte (INCY - Free Report) announced that the phase III, randomized, placebo-controlled BREEZE-AD4 study on oral JAK inhibitor, Olumiant (baricitinib), was successful.

BREEZE-AD4 is a multicenter, double-blind, randomized, placebo-controlled study conducted outside of the United States. The study evaluated the efficacy and safety of 1 mg, 2 mg and 4 mg doses of baricitinib in combination with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD), who have experienced failure to cyclosporine or are intolerant to or have a contraindication to cyclosporine.

The primary endpoint was defined by the proportion of patients achieving at least a 75% or greater change from baseline in their Eczema Area and Severity Index (EASI) at Week 16.

Results show that the 4 mg dose of baricitinib plus TCS met the primary endpoint.

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.

Lilly has already submitted baricitinib for regulatory review in Europe as a treatment for patients with moderate-to-severe AD. The company also plans to file for approval in the United States and Japan in 2020.

A potential label expansion should boost the drug’s sales, which came in at $299.1 million in the first nine months of 2019.

Lilly’s shares have rallied 20.2% in the past year compared with the industry’s growth of 15.7%.

However, competition is stiff in the AD space from the likes of Regeneron (REGN - Free Report) and Sanofi’s (SNY - Free Report) Dupixent, which holds a dominant position in the same.

Lilly currently carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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