ZUG, Switzerland, January 22, 2015 /PRNewswire/ --
For Release to Pan-European Media Only
Shire plc (LSE: SHP, NASDAQ: SHPG) today announces the positive response from the European Decentralised Procedure (DCP) for Elvanse Adult® in the three European countries participating in the procedure (UK, Denmark and Sweden).
Elvanse Adult was accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in February 2014. The application was based on four Phase III studies designed to assess the efficacy and safety of Elvanse Adult in adults with attention deficit/hyperactivity disorder (ADHD).[2-5]
The UK MHRA acted as the Reference Member State on behalf of the three European countries. Product labelling has been agreed by these countries, who will now issue their national Marketing Authorisations (approvals). This typically takes a further one to three months, however timings for this process vary between countries. On grant of Marketing Authorisation, Elvanse Adult will be indicated as part of a comprehensive treatment programme for ADHD in adult patients.
"We are delighted to be so close to the first European approvals of Elvanse Adult, for the UK, Denmark and Sweden," said Dr. Philip J. Vickers, Global Head of Research and Development, Shire. "In Europe the choice of licensed medications for diagnosed adults with ADHD is currently limited. After receipt of regulatory approval, we will work closely with the respective countries to ensure that Elvanse Adult is made available to patients as soon as possible."
About Adult ADHD
ADHD is a common psychiatric disorder in children, adolescents, and adults. While commonly thought of as a childhood condition, ADHD persists to adulthood in a reported 50-66% of individuals diagnosed with the disorder in childhood.[10-13] Worldwide, 3.4% (range 1.2-7.3%) of adults aged 18-44 are thought to have ADHD.
ADHD can affect many aspects of adults' lives including educational and occupational underachievement, and problems with relationships.,
About Elvanse Adult
Elvanse Adult (lisdexamfetamine dimesylate) is a single-daily dose, long-acting, prodrug stimulant which is indicated as part of a comprehensive treatment programme for ADHD in adults. The decision to use Elvanse Adult must take into consideration the profile of the patient, including a thorough assessment of the severity and chronicity of the patient's symptoms, clinical response to previous pharmacotherapies and/or the potential for abuse, misuse or diversion.
The prodrug technology of Elvanse Adult means that the inactive molecule is gradually converted in the blood, making the active part of the medicine, d-amfetamine (d-AMF), available in the body over a period of time.,
d-AMF is thought to work by increasing the levels of neurotransmitters (chemicals that are stored in nerve cells in the brain and nervous system, which transmit messages between the nerve cells) responsible for activity, attention and concentration.
Elvanse Adult will be indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adult patients.
Elvanse Adult will not be indicated in all adult patients and the decision to use the medicinal product must take into consideration the profile of the patient, including a thorough assessment of the severity and chronicity of the patient's symptoms, the potential for abuse, misuse or diversion and clinical response to any previous pharmacotherapies for the treatment of ADHD.
Elvanse Adult safety information
Hypersensitivity to sympathomimetic amines or any of the excipients, concomitant use of monoamine oxidase inhibitors (MAOI) or within 14 days after MAOI treatment (hypertensive crisis may result), hyperthyroidism or thyrotoxicosis, agitated states, symptomatic cardiovascular disease, advanced arteriosclerosis, moderate to severe hypertension, glaucoma.
Special warnings and precautions for use
Elvanse Adult is a stimulant, and when approved, will have a potential for abuse, misuse, or diversion that physicians should consider when prescribing this product. The risk of misuse may be greater in adults (especially young adults) than in paediatric use. Stimulants should be prescribed cautiously to patients with a history of substance abuse or dependence.
The following warnings and precautions need to be taken into account: potential of abuse and dependence, cardiovascular adverse events, psychiatric adverse events, clinical evaluation for tics, monitoring of long-term effect on weight, seizures, visual disturbance, prescribing and dispensing, and use with other sympathomimetic drugs.
Very common Decreased appetite, insomnia, dry mouth and (frequency headache. greater than or equal to 1/10): Common Agitation, anxiety, libido decreased, (greater than or psychomotor hyperactivity, bruxism, equal to 1/100 to dizziness, restlessness, tremor, tachycardia, <1/10): palpitation, dyspnoea, diarrhoea, constipation, upper abdominal pain, nausea, hyperhidrosis, erectile dysfunction, irritability, fatigue, feeling jittery, blood pressure increased and weight decreased. Uncommon Hypersensitivity, logorrhea, depression, tic, (greater than or affect lability, dysphoria, euphoria, equal to 1/1000 to dermatillomania, mania, somnolence, <1/100): dyskinesia, vision blurred, vomiting, urticaria, rash and pyrexia.
For a complete overview of rare (≥1/10000 to <1/1000); very rare (<1/10000), not known (cannot be estimated from the available data) side effects, please consult to the four Phase III studies that were part of the application.[2-5]
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts 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, that:
- Shire's products may not be a commercial success;
- revenues from ADDERALL XR are subject to generic erosion and revenues from INTUNIV will become subject to generic competition starting in December 2014;
- the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire's products may impact future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its Rare Diseases 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 development, approval and manufacturing of Shire's products is subject to extensive oversight by various regulatory agencies. Submission of an application for regulatory approval of any of our product candidates, such as our planned submission of a New Drug Application to the FDA for Lifitegrast, may be delayed for any number of reasons and, once submitted, may be subjected to lengthy review and ultimately rejected. Moreover, regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- 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 impact Shire's revenues, financial condition or results of operations;
- 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;
- adverse outcomes in legal matters 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 Shire's revenues, financial condition or results of operations;
- Shire faces intense competition for highly qualified personnel from other companies, academic institutions, government entities and other organizations. Shire is undergoing a corporate reorganization and the consequent uncertainty could adversely impact Shire's ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
- failure to achieve Shire's strategic objectives with respect to the acquisition of ViroPharma Incorporated may adversely affect Shire's financial condition and results of operations;
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 Annual Report on Form 10-K for the year ended December 31, 2013.
- Medicines and Healthcare Products Regulatory Agency. (2015). Public Assessment Report Decentralised Procedure, Elvanse Adult, Lisdexamfetamine dimesylate, Shire Pharmaceuticals Contracts Limited.
- ADLER LA. et al. (2008). Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. Journal of Clinical Psychiatry. Sep;69(9):1364-73.
- WIGAL T et al. (2010). Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design. Behavioral and Brain Functions. 6:34:1-1
- BRAMS M. et al. (2012). Maintenance of Efficacy of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder: Randomized Withdrawal Design. Journal of Clinical Psychiatry. 73(7):977-983.
- ADLER LA et al. (2013). Lisdexamfetamine Dimesylate in Adults with attention deficit hyperactivity disorder who report clinically significant impairment in executive function: results from a randomized, double blind, placebo-controlled study. Journal of Clinical Psychiatry. 74:694-702
- Draft Elvanse Adult Summary of Product Characteristics, Shire Pharmaceuticals Limited.
- PLISZKA S & the AACAP Work Group on Quality Issues. Practice Parameter For The Assessment And Treatment Of Children And Adolescents With Attention-Deficit/Hyperactivity Disorder. (2007). Journal of the American Academy of Child & Adolescent Psychiatry. 46(7):894-921.
- MCCARTHY S. et al. (2012). The Epidemiology Of Pharmacologically Treated Attention Deficit Hyperactivity Disorder (ADHD) In Children, Adolescents And Adults In UK Primary Care. BMC Pediatrics.12:78.
- FAYYAD J. et al. (2007). Cross-national prevalence and correlates of adult attention-deficit hyperactivity disorder. The British Journal of Psychiatry. 190:402-409.
- LARA C. et al. (2009). Childhood Predictors Of Adult Attention-Deficit/Hyperactivity Disorder: Results From The World Health Organization World Mental Health Survey Initiative. Biological Psychiatry. 65:46-54.
- FARAONE SV. et al. (2006). The Age-Dependent Decline Of Attention Deficit Hyperactivity Disorder: A Meta-Analysis Of Follow-Up Studies. Psychological Medicine. 36:159-165.
- BARKLEY RA. et al. (2002). The Persistence Of Attention-Deficit/Hyperactivity Disorder Into Young Adulthood As A Function Of Reporting Source And Definition Of Disorder. Journal of Abnormal Psychology. 111:279-289.
- EBEJER JL. et al. (2012). Attention Deficit Hyperactivity Disorder In Australian Adults: Prevalence, Persistence, Conduct Problems And Disadvantage. PLoS One. 7:e47404.
- BIEDERMAN J et al. (2006). Functional impairments in adults with self-reports of diagnosed ADHD: A controlled study of 1001 adults in the community. Journal of Clinical Psychiatry. 67:524-540.
- GUDJONSSON GH et al. (2009). The relationship between satisfaction with life, ADHD symptoms, and associated problems among university students. J Atten Disord, 12:507-515.
- PENNICK M. (2010). Absorption of Lisdexamfetamine Dimesylate and its Enzymatic Conversion to d-Amphetamine. Neuropsychiatric Disease and Treatment. 6:317-327.
- ERMER J et al. (2010). Lisdexamfetamine Dimesylate: Linear Dose-Proportionality, Low Intersubject and Intrasubject Variability, and Safety in an Open-Label Single-Dose Pharmacokinetic Study in Healthy Adult Volunteers. Journal of Clinical Psychiatry. 73:977-983.
- HODGKINS P. et al. (2012) Amfetamine and methylphenidate medications for attention-deficit/hyperactivity disorder: complementary treatment options. European Child Adolescent Psychiatry 2012; 21: 477-492.
Date of Preparation: January 2015
Zinc Job Number: INTSP/C-ANPROM /NBU/14/0097
SOURCE Shire plc