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Lilly's (LLY) Olumiant Dermatitis sNDA Review Gets Delayed

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Eli Lilly and Company LLY and partner Incyte INCYannounced that the FDA has extended the review timeline for their supplemental new drug application (sNDA) for Olumiant (baricitinib) by three months.

The sNDA was seeking approval of Olumiant, an oral JAK inhibitor, for another indication — moderate-to-severe atopic dermatitis (AD). The FDA extended the review period as it needs time to review additional data submitted by Lilly on the agency’s request. The FDA’s decision is now expected in the third quarter of 2021.

Olumiant is already approved in Europe and Japan for atopic dermatitis. Olumiant is presently approved to treat rheumatoid arthritis in several countries. Olumiant was also granted Emergency Use Authorization (EUA) for use in combination with Gilead’s GILD remdesivir to treat hospitalized COVID-19 patients in November last year. It is also being evaluated for alopecia areata, systemic lupus erythematosus, and juvenile idiopathic arthritis.

The drug generated sales of $638.9 million in 2021, recording an increase of 50% year over year.

Lilly’s shares have risen 8.2% this year so far against the industry’s decline of 0.3%.

We remind investors that recently the FDA also extended the review timeline for two sNDAs for AbbVie’s ABBV JAK inhibitor drug, Rinvoq (upadacitinib) by three months. The sNDAs were seeking approval for Rinvoq for atopic dermatitis and active psoriatic arthritis. Rinvoq is presently approved for treating moderate-to-severe rheumatoid arthritis. Meanwhile, the FDA issued a statement in February related to another JAK inhibitor, Pfizer’s Xeljanz that stated that the drug may increase the risk of heart-related problems and cancer. The statement was based on data from a study that compared the drug to another class of drugs — tumor necrosis factor (TNF) inhibitors.

The extension of review periods for sNDAs and other negative updates for JAK Inhibitor drugs fuel the curiosity of some analysts that this might not be drug-specific issue but may be related to the JAK inhibitors class of drugs

Lilly currently has 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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