Pharma giant Eli Lilly and Company LLY announced positive top-line results from a second phase III study on its arthritis drug, Taltz (ixekizumab), for the treatment of Ankylosing Spondylitis (AS), also known as radiographic axial spondyloarthritis (r-axSpA).
The phase III study, COAST-W, evaluated the safety and efficacy of Taltz for the treatment of AS. This is the first AS trial on a patient population with inadequate response to one or two tumor necrosis factor (TNF) inhibitors or intolerance to a TNF inhibitor.
The results showed that Taltz demonstrated a statistically significant improvement in the signs and symptoms of AS, measured by the proportion of patients having achieved Assessment of Spondyloarthritis International Society 40 (ASAS40) response at 16 weeks when compared with placebo. The study met the primary and major secondary endpoints.
AS is a type of spondyloarthritis affecting the pelvic joints and spine.
Notably, the company had earlier reported positive results from the phase III COAST-V study on Taltz for the therapy of AS.
Lilly plans to submit detailed data from the COAST-W study at scientific meetings and in peer-reviewed journals later in 2018. Based on the positive results from the COAST-V and COAST-W studies, the company plans to submit the same for approval in the United States later this year.
We like to remind investors that apart from psoriatic arthritis, Taltz is approved for treating moderate-to-severe plaque psoriasis in adults, eligible for systemic therapy or phototherapy, as well as for active psoriatic arthritis. Although many other drugs like Novartis’ NVS Cosentyx and AbbVie’s ABBV Humira are approved to treat plaque psoriasis, Lilly claims Taltz is now the first and the only FDA approved treatment for genital psoriasis.
Taltz logged sales of $146.5 million in the first quarter. The label expansion will in turn, expand the eligible patient population of the drug, driving sales going forward. The drug recorded sales of $559.2 million in 2017.
Shares of Lilly have inched up 1.3% year to date against the industry’s decline of 6.1%.
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Lilly currently carries a Zacks Rank #3 (Hold). Another top ranked stock in the same sector is H Lundbeck A/S HLUYY which carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
H Lundbeck’s earnings estimates have been revised 11.6% upward for 2018 and 4.3% for 2019 in the past 60 days. The stock has surged 34.1% year to date.
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