Slingshot members are tracking this event:
Lilly Receives Positive CHMP Opinion for Ixekizumab for the Treatment of Moderate-to-Severe Plaque Psoriasis
Do you think this event is important to the companies below? How will it affect their stock price?
|Impact on Stocks
|LLY||Community voting in process|
The CHMP positive opinion for ixekizumab was based on findings from the largest Phase 3 trial program in moderate-to-severe plaque psoriasis evaluated by regulatory authorities to date. This clinical program included three double-blind, multicenter, Phase 3 studies—UNCOVER-1, UNCOVER-2 and UNCOVER-3—which demonstrated the safety and efficacy of ixekizumab in more than 3,800 patients in 21 countries with moderate-to-severe plaque psoriasis. All three studies evaluated the safety and efficacy of ixekizumab (80 mg every two weeks, following a 160-mg starting dose) compared to placebo after 12 weeks. UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks.
In these studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index (PASI) 75 and static Physician's Global Assessment (sPGA) 0 or 1.1 PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician's assessment of severity of a patient's psoriasis lesions overall at a specific point in time and is a required measure the FDA uses to evaluate effectiveness.
Slingshot Insights Explained
Feb 26, 2016
Don’t see a project related to the catalyst you care about?
Related Keywords Chmp, Ixekizumab, Moderate-to-severe Plaque Psoriasis