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SHP465

Treatment for: Attention-Deficit/Hyperactivity Disorder (ADHD)

U.S. FDA Acknowledges Receipt of Shire’s New Drug Application for SHP465 for ADHD

Lexington, Mass., USA – January 19, 2017 –– Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation. SHP465 is being evaluated as a potential once-daily treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). 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.

“Our progress with the SHP465 clinical development program underscores Shire’s commitment to supporting the needs of patients living with ADHD in the U.S.,” said Philip Vickers, PhD, Global Head of Research and Development, Shire. “Since our first submission, our understanding of ADHD and adult patients’ needs has evolved, and we believe the additional studies in our filing fulfill the request from the FDA. With the potential of once-daily dosing, SHP465, if approved, could help patients address the ongoing challenges of ADHD symptoms.”

“As the medical community broadens its understanding of ADHD and the ways it impacts people differently, it is important to expand the long-acting treatment options available to health care professionals to address patient needs,” said Andrew J. Cutler, MD, Executive Vice President and Chief Medical Officer at Meridien Research and an investigator in the SHP465 clinical trials. “It’s encouraging to see that health care professionals and their patients living with ADHD may have more options available to them.”

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 U.S. 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.

Protection for Shire’s ADHD Franchise Extends to 2029

There are patents supporting Shire’s overall ADHD franchise in the U.S. 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.

About ADHD

Attention-Deficit/Hyperactivity Disorder is a neurodevelopmental disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and is inconsistent with developmental level.

An estimated 4.4 percent of adults have ADHD in the U.S. When applied to the full U.S. adult population aged 18 and over, approximately 10.5 million adults are estimated to have ADHD in the U.S.

The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5®) or International Classification of Diseases, 10th revision (ICD-10). Only a trained health care professional can evaluate and diagnose ADHD.

Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms. Standard treatments include educational approaches, psychological therapies which may include behavioral modification and/or medication. Ongoing assessment and treatment may be necessary.

DSM-5® is a registered trademark of the American Psychiatric Association.

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Forward-Looking Statements

Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:

• Shire’s products may not be a commercial success;
• increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire’s future revenues, financial condition and results of operations;
• Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
• the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
• certain of Shire’s therapies involve lengthy and complex processes, which may prevent Shire from timely responding to market forces and effectively managing its production capacity;
• Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
• the actions of certain customers could affect Shire’s ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;
• Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
• adverse outcomes in legal matters, tax audits and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the combined company’s revenues, financial condition or results of operations;
• inability to successfully compete for highly qualified personnel from other companies and organizations;
• failure to achieve the strategic objectives with respect to Shire’s acquisition of NPS Pharmaceuticals, Inc., Dyax Corp. (“Dyax”) or Baxalta Inc. (“Baxalta”) may adversely affect Shire’s financial condition and results of operations;
• Shire’s growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
• a slowdown of global economic growth, or economic instability of countries in which Shire does business, as well as changes in foreign currency exchange rates and interest rates, that adversely impact the availability and cost of credit and customer purchasing and payment patterns, including the collectability of customer accounts receivable;
• failure of a marketed product to work effectively or if such a product is the cause of adverse side effects could result in damage to the Shire’s reputation, the withdrawal of the product and legal action against Shire;
• investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
• Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
• Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which may decrease its business flexibility and increase borrowing costs;
• difficulties in integrating Dyax or Baxalta into Shire may lead to the combined company not being able to realize the expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all; and
• other risks and uncertainties detailed from time to time in Shire’s filings with the Securities and Exchange Commission, including those risks outlined in “ITEM 1A: Risk Factors” in Shire’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.

All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.

Source: Shire plc

Posted: January 2017

SHP465 FDA Approval History

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