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 3 studies designed to assess the efficacy and safety of Elvanse Adult in adults with ADHD.
The UK MHRA acted as the Reference Member State on behalf of the three European countries. Product labelling has been agreed by these countries, which will now issue their national Marketing Authorisations (approvals). This typically takes one to three months, however, the timing for this process varies among countries.
“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.”
Lisdexamfetamine dimesylate is available for children six years of age and over, adolescents and adults in the USA and Canada (brand name Vyvanse) and in Brazil (brand name Venvanse).
In addition, lisdexamfetamine dimesylate is currently available in eight European countries indicated as part of a comprehensive treatment programme for ADHD in children and adolescents 6 years of age and over when response to previous methylphenidate treatment is considered clinically inadequate (brand names Elvanse®â–¼ /Tyvense®â–¼).
CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
ADHD is a common psychiatric disorder in children, adolescents and adults. While commonly thought of as a childhood condition, nearly 50% of children with ADHD may continue to meet the criteria for the disorder in adulthood, based on parent report. Worldwide, 3.4% (range 1.2-7.3%) of adults aged 18-44 are thought to have ADHD based on the World Health Organization World Mental Health Survey Initiative.
Elvanse Adult is indicated as part of a comprehensive treatment programme for attention deficit/hyperactivity disorder (ADHD) in adult patients.
Elvanse Adult is not 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 medical history 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.
Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep in a safe place to prevent misuse and abuse. Selling or sharing Vyvanse may harm others and is illegal.
Vyvanse is indicated for the treatment Attention-Deficit/Hyperactivity Disorder (ADHD) in patients 6 years and above. Vyvanse capsules are currently available in seven dosage strengths of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.
- is taking or has taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI
- is sensitive to, allergic to, or had a reaction to other stimulant medicines
- sudden death in people who have heart problems or heart defects
- sudden death, stroke and heart attack in adults
- increased blood pressure and heart rate
Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. The doctor should check your or your child’s blood pressure and heart rate regularly during treatment.
Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.
2. Mental(psychiatric) problems including:
- new or worse behavior and thought problems
- new or worse bipolar illness
In Children and Teenagers
- new psychotic symptoms such as:
- seeing things or hearing voices that are not real
- believing things that are not true
- being suspicious
- new manic symptoms
Tell your doctor about any drug abuse, alcohol abuse or mental problems that you or your child has had, or about a family history of suicide, bipolar illness, or depression.
Call your doctor right away if you or your child has any new or worsening mental symptoms or problems while taking Vyvanse.
3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:
Call your doctor right away if you have or your child has any of these signs or symptoms or develops unexplained wounds on fingers or toes while taking Vyvanse.
For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.
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Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal, and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmology.
Statements included in this communication 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:
and other risks and uncertainties detailed from time to time in Shire’s or NPS Pharma’s filings with the U.S. Securities and Exchange Commission, including their respective most recent Annual Reports on Form 10-K.
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