Lilly's Olumiant Meets Primary Endpoint in 3rd Eczema Study

Eli Lilly & Company LLY and partner Incyte’s INCY oral JAK inhibitor, Olumiant (baricitinib) met the primary endpoint in a pivotal late-stage study evaluating it in a new indication — moderate-to-severe atopic dermatitis (AD), a type of eczema.

Notably, top-line results from the phase III BREEZE-AD7 study showed that after 16 weeks of treatment, patients treated with baricitinib plus standard-of-care topical corticosteroids experienced a significant improvement in disease severity — the primary endpoint — compared to those treated with placebo. The primary endpoint was defined by the validated Investigator's Global Assessment for AD (vIGA) score of "clear or almost clear" skin. Lilly said that the safety data was consistent with previous studies on baricitinib.

So far this year, shares of Lilly have declined 5.3% compared with the industry's decrease of 2.8%.

Lilly is conducting five studies on baricitinib under the AD program and BREEZE-AD7 is the third study to be completed this year. BREEZE-AD1 and BREEZE-AD2 were the other two studies wherein baricitinib 4 mg and 2 mg both met the primary endpoint. Top-line data from the remaining two studies are expected to be presented later this year or early next year

Olumiant is presently marketed globally for the treatment of moderate-to-severe rheumatoid arthritis. However, while it was approved for both the 2 mg and 4 mg dose in the EU in 2017, it was approved only for the lower dose in the United States in 2018, after being rejected by the FDA in 2017. The FDA did not approve the higher dose (4 mg) and the drug’s label was approved with a boxed warning, stating risk of serious infections, malignancies and thrombosis.

Other than atopic dermatitis, Olumiant is also being studied in phase III studies for systemic lupus erythematosus and in a phase II/III study in alopecia areata.

Olumiant generated sales of $184.5 million in the first half of 2019 backed by launch uptake in new European markets. If the drug is approved for additional indications, it can bring in more sales for Lilly.

Baricitinib is being co-developed by Lilly and Incyte under an exclusive global license and collaboration agreement inked in December 2009.

Last week, AbbVie ABBV gained FDA approval for its JAK inhibitor, upadacitinib, for the treatment of moderate-to-severe RA in patients who experience inadequate response or are intolerant to methotrexate. The drug will be marketed with the trade name of Rinvoq. The company is expected to launch the drug later this month. Upadacitinib is also being studied in a late-stage study for AD.

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

Another large-cap pharma stock with the same Zacks Rank as Lilly is Novartis NVS. Novartis’ earnings estimates for 2019 have gone up 1.8% while that for 2020 have increased 0.4% over the past 30 days. Novartis stock has returned 3.1% so far in 2019.

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