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Lilly's (LLY) Taltz Gets FDA Nod for Ankylosing Spondylitis

Zacks Equity Research

Eli Lilly and Company LLY announced that the FDA has approved its psoriasis drug Taltz (ixekizumab) for a new indication. Taltz injection (80 mg/mL) is now approved for the treatment of adult patients with ankylosing spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA). This is the third indication for the drug.

Taltz was evaluated in two randomized, placebo-controlled phase III studies, which demonstrated its efficacy and safety in 657 adult patients with active AS. In both studies, Taltz achieved the primary efficacy endpoint, which was to see the proportion of patients achieving Assessment of Spondyloarthritis International Society 40 (ASAS40) response at 16 weeks of treatment compared to placebo.

Moreover, patients treated with Taltz also demonstrated statistically significant improvements in key secondary endpoints in both the studies.

AS is a type of spondyloarthritis affecting the pelvic joints and the spine.

Shares of Lilly inched up almost 2.1% following this news on Monday. However, the stock has lost 3.4% so far this year, wider than the industry’s decrease of 2.1%.

Taltz is presently marketed for moderate-to-severe plaque in adults, who are candidates for systemic therapy or phototherapy and also for those with active psoriatic arthritis (PsA).

Notably, apart from Taltz, other drugs having got the nod to treat plaque psoriasis are Novartis’ NVS Cosentyx, AbbVie’s ABBV Humira and Johnson & Johnson’s JNJ new drug Tremfya.

Earlier this month, Lilly announced that Taltz was found superior to J&J’s Tremfya (guselkumab) in delivering total skin clearance at week 12 in a head-to-head comparison study, which evaluated the efficacy between Taltz and Temfya.

Top-line data from the study showed that a higher proportion of patients treated with Taltz achieved complete skin clearance compared to Tremfya as measured by PASI 100, thereby meeting the study’s primary endpoint.

Taltz is an important revenue driver for Lilly, generating sales of $606.3 million in the first half of 2019. The figure is up 65% year over year. The label expansion will increase the strength of eligible patient population for the drug, which should drive its sales going forward.

Zacks Rank

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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