Shire will drop MDD indication for Vyvanse after failed endpoints in Ph III

Shares of Ireland-headquartered Shire (LSE: SHP) fell 2.4% to £30.67 in early trading, after the company presented disappointing top-line results from two pivotal Phase III investigational studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate) capsules (CII) versus placebo as an adjunctive treatment for major depressive disorder (MDD) in adults who inadequately responded to antidepressant monotherapy with a SSRI or SNRI.

Attention-deficit hyperactivity disorder (ADHD) drug Vyvanse did not meet the primary efficacy endpoint versus placebo for either study. The safety profile for Vyvanse in these two studies appears to be generally consistent with the known profile established in studies in adults with ADHD. Based on these clinical trial results, Shire will no longer pursue this clinical development program. The MDD indication had been forecast as having $1 billion sales potential, while Shire has recently said that, in the current ADHA indication sales this year will reach around $1,2 billion.

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