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Lilly depression drug fails late-stage trials

Will not pursue edivoxetine as an add-on treatment for depression
Eli Lilly HQ

There was disappointment for Lilly this week after its prospective depression treatment edivoxetine failed to meet the primary objectives of three late-stage studies.

The drug was unable to demonstrate it was significantly superior to placebo, based on the Montgomery-Asberg Depression Rating Scale, when added to a selective serotonin reuptake inhibitor (SSRI) in people with major depressive disorder.

“While the safety and tolerability of edivoxetine was consistent with previous studies, the efficacy results do not support a regulatory submission for adjunctive treatment in patients with major depressive disorder,” said the company.

David Ricks, senior vice president, and president, Lilly Bio-Medicines, confirmed that the company “will not proceed with development of edivoxetine as an add-on treatment for depression”.

As a result, Lilly expects to incur a $15m charge in the fourth quarter of 2013.

The drug had previously shown promise as a highly selective norepinephrine reuptake inhibitor (SNRI), which would complement the action of an SSRI.

It is the latest in a string of trial failures for Lilly this year, with the company dropping development of enzastaurin in lymphoma, ramucirumab in breast cancer and tabalumab in rheumatoid arthritis.

The company also abandoned a phase II trial of Alzheimer's disease drug candidate LY2886721 after some patients experienced abnormal liver function.

Nevertheless, Derica Rice, Lilly's executive vice president, global services and chief financial officer, was confident about the company's pipeline of products.

He said: “This year alone, we submitted four potential new medicines to regulatory authorities with more anticipated next year. In addition, we expect to begin launching new products in 2014 and are on track to return to revenue growth and margin expansion in 2015 and beyond."

6th December 2013

From: Research



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