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Eli Lilly & Company LLY announced that the FDA has approved the inclusion of additional data on the label of its psoriasis injection, Taltz. With the latest approval, Taltz label will now include data for psoriasis involving the genital area, which impacts roughly 63% of psoriasis patients over the course of their disease.
Taltz is already marketed for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy as well as for active psoriatic arthritis. Taltz works by specifically targeting IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.
The drug recorded sales of $146.5 million in the first quarter of 2018. The label expansion will expand the eligible patient population of the drug, which should drive sales going forward.
The approval for genital psoriasis was based on data from a study evaluating patients with moderate-to-severe psoriasis involving the genital area. In the study, Taltz demonstrated a significant improvement compared to placebo at 12 weeks in the severity of psoriasis affecting the genital area, overall psoriasis, genital itch and the impact of genital psoriasis on sexual activity in such patients.
Though many other drugs like Novartis’ NVS Cosentyx, J&J’s JNJ Tremfya and AbbVie’s ABBV Humira are approved to treat plaque psoriasis, Lilly claims Taltz is now the first and only FDA approved treatment for genital psoriasis
Taltz is also being studied in a late-stage study for axial spondyloarthritis.
Year to date, Lilly’s shares have declined 2.6% compared with the industry’s decline of 3.8%.
Lilly currently 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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