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US FDA Acknowledges Receipt of Shire NDA for SHP465 for ADHD.

M2 PHARMA-January 23, 2017-US FDA Acknowledges Receipt of Shire NDA for SHP465 for ADHD


- The US Food and Drug Administration has acknowledged receipt of Irish biotechnology company Shire plc's (LSE: SHP) (NASDAQ: SHPG) Class 2 resubmission of a New Drug Application for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation, the company said.

SHP465 is being evaluated as a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder.

The FDA is expected to provide a decision on or around June 20, 2017, the designated Prescription Drug User Fee Act (PDUFA) action date.

Shire resubmitted the NDA for SHP465 in response to the Approvable Letter from the FDA (May 18, 2007) that requested additional clinical studies and classified the response as a Class 2 resubmission with a review goal of six months.

The NDA for SHP465 includes data from a database of 16 clinical studies evaluating SHP465 in more than 1,600 subjects, including data resulting from a US FDA request to conduct a short-term efficacy and safety study in pediatric patients with ADHD (aged 6-17).

Positive top-line results from that study, SHP465-305, were reported in April 2016. The NDA also includes results from SHP465-306, a short-term efficacy study in adults, for which positive top-line results were announced in June 2016.

In earlier adolescent and adult clinical studies, SHP465 demonstrated a statistically significant difference versus placebo at 16 hours post-dosing, with onset of action starting 2 or 4 hours post-dosing, as measured by the Permanent Product Measure of Performance (PERMP). PERMP is an objective, validated, skill-adjusted math test that measures attention in ADHD.

The most common adverse reactions in Phase 3 studies (incidence >=5% and at a rate at least twice placebo) in children, adolescents, and/or adults with ADHD were insomnia, decreased appetite, dry mouth, decreased weight, increased heart rate, anxiety, nausea, upper abdominal pain, irritability and dizziness.

There are patents supporting Shire's overall ADHD franchise in the US that extend to 2029. If approved, Shire expects that SHP465 will have three years of Hatch-Waxman exclusivity and at least three patents listed in the FDA Orange Book expiring as late as May 2029.

Launch is planned for the second half of 2017.

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Publication:M2 Pharma
Date:Jan 23, 2017
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