Lilly to Seek Approval For Psoriasis Drug

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Indianapolis-based Eli Lilly and Co. (NYSE: LLY) is expected to submit psoriasis drug Ixekizumab for approval next year. The drugmaker says the treatment met all primary objectives in recent studies. August 21, 2014

News Release

INDIANAPOLIS, Ind. -- Drugmaker Eli Lilly and Co. (LLY) said Thursday that its investigational psoriasis drug Ixekizumab is statistically superior to etanercept and placebo on all skin clearance measures in late stage studies on patients with moderate-to-severe plaque psoriasis. The company revealed this while disclosing top-line results from its pivotal UNCOVER studies in moderate-to-severe plaque psoriasis.

Based on the positive data from the studies, Lilly plans regulatory submissions for ixekizumab in the first half of 2015. Ixekizumab is also in clinical development for the treatment of psoriatic arthritis.

Eli Lilly said it met all primary and key secondary objectives across three pivotal studies of 3,866 patients, which is the largest late stage moderate-to-severe plaque psoriasis program to date.

"These data are important for people suffering from moderate-to-severe plaque psoriasis, as up to 41 percent of those treated with ixekizumab were able to achieve clear skin at week 12, with just one injection per dose. These results give us confidence that if approved, ixekizumab could make complete resolution of psoriasis possible for significantly more people," said David Ricks, Lilly senior vice president, and president, Lilly Bio-Medicines.

Under the late stage studies, UNCOVER-1 compared the safety and efficacy of different dosing regimens of ixekizumab to placebo after 12 weeks and 60 weeks of treatment. Meanwhile, UNCOVER-2 and 3 evaluated different dosing regimens of ixekizumab compared to either placebo or etanercept for 12 weeks.

The company noted that patients treated with both dosing regimens of ixekizumab had significantly greater levels of skin clearance compared to placebo and to etanercept at the 12-week endpoint.

The data from the studies showed statistically significant improvements in skin clearance measures as early as the first week for patients treated with ixekizumab when compared to either placebo or etanercept, and continued through week 12.

For patients treated with ixekizumab either every four weeks or every two weeks, between 78 to 90 percent of patients achieved at least a 75 percent reduction in the Psoriasis Area and Severity Index or PASI score (PASI 75) at 12 weeks.

Additionally, 31 to 41 percent of these patients achieved PASI 100, or clear skin, at week 12. For comparison, only between 5 to 7 percent of patients treated with etanercept in the UNCOVER-2 and 3 studies achieved PASI 100.

"Moderate-to-severe plaque psoriasis can have a devastating life impact for patients. Clear skin is their goal, but many patients are not able to achieve complete resolution using currently-available treatments," Ricks added.

Psoriasis is a chronic, noncontagious auto-inflammatory disease that appears on the skin. It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells. It is the most common inflammatory disease in the U.S., affecting as many as 7.5 million Americans and an estimated 125 million people worldwide.

Source: Eli Lilly and Co.