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Lilly’s (LLY) Taltz Gets Approval for Label Expansion in US


Eli Lilly and Company LLY announced that the FDA has approved the label expansion of its psoriasis drug, Taltz, to include the treatment of active psoriatic arthritis (PsA) in adults.

We note that Taltz is presently approved for treating moderate-to-severe plaque psoriasis in adults who can have systemic therapy or phototherapy.

The drug has grown more than 50% in the first nine months of 2017 and contributed significantly to revenues and volumes. This approval for an expanded label in the United States is expected to further boost its growth.

Lilly’s stock price has increased 26.9% in the past one year, outperforming the industry’s gain of 20%.

Coming back to the news, the FDA’s approval for Taltz’ label expansion was based on data from two phase III studies – SPIRIT-P1 and SPIRIT-P2 – evaluating the drug in active PsA patients, who have not received any antirheumatic drug therapy or who have failed one or two tumor necrosis factor (“TNF”) inhibitors, respectively.

The drug achieved a reduction of 20% or more in a composite measure of disease activity (ACR20) in more than half of the patient population in both the studies at 24 weeks.

The drug (80 mg/mL) can be injected as single agent or in combination with any disease-modifying antirheumatic drug like methotrexate.

However, Taltz will face competition from several drugs, especially Novartis’ NVS Cosentyx, as both the drug works by targeting IL-17A. Cosentyx is also approved for PsA and plaque psoriasis.

PsA is a chronic form of inflammatory arthritis, which is painful and progressive as well. Per the press release, approximately 1.6 million people in the United States are affected by the disease. Apart from Cosentyx, Johnson & Johnson’s JNJ Stelara and AbbVie Inc.’s ABBV Humira among others are fighting for market share.

Lilly 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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