PHILADELPHIA, PA, USA I September 15, 2014 I Shire plc (LSE: SHP, NASDAQ: SHPG), the global specialty biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has accepted for filing with priority review a supplemental New Drug Application (sNDA) for Vyvanse® (lisdexamfetamine dimesylate) Capsules (CII) as a treatment for adults with binge eating disorder (BED). The FDA is expected to provide a decision in February 2015, based on the anticipated Prescription Drug User Fee Act (PDUFA) action date.
“The decision from the FDA to accept our filing for priority review not only marks progress in the development of Vyvanse for adults with BED, but underscores this is an area of unmet medical need as there are currently no approved pharmacologic options for these patients,” said Phil Vickers, PhD, Head of Research and Development, Shire.
Vyvanse is a prescription medicine currently only approved for Attention-Deficit/Hyperactivity Disorder (ADHD). Vyvanse should only be used to treat 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.
Shire is seeking approval for Vyvanse as a treatment option for adults with BED based on the results of two identically designed randomized placebo-controlled Phase 3 studies evaluating the efficacy and safety of Vyvanse versus placebo, previously announced in a press release dated November 5, 2013.[1]
About BED
BED is a distinct eating disorder now recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5®).[2]BED is characterized by recurring episodes of eating significantly larger amounts of food in a discrete period of time (eg, any two-hour period) than most people would eat in a similar period of time under similar circumstances.[2] These episodes are associated with feelings of distress and lack of control (eg, the sense one cannot stop eating or control what or how much one is eating).[2]
As described in DSM-5, a person with BED may eat much more rapidly than normal, eat until feeling uncomfortably full, eat large amounts of food when not feeling physically hungry, eat alone to hide the behavior due to embarrassment, or experience feelings of disgust, depression or guilt after a binge episode.[2] In these individuals, binge eating occurs, on average, at least once a week for three months.[2] Unlike bulimia nervosa and anorexia nervosa, BED is not associated with the recurrent use of inappropriate behaviors to compensate for binge eating (eg, purging, excessive exercise or fasting).[2]
About VYVANSE (lisdexamfetamine dimesylate)
Vyvanse is a prescription medicine currently only approved in the United States, Canada, Australia, several European countries (trade name: Elvanse®/Tyvense®) and Brazil (trade name: Venvanse™) for ADHD. Vyvanse should only be used to treat ADHD. Vyvanse should only be used in accordance with locally approved prescribing information.
INDICATION
Vyvanse is a prescription medicine for the treatment of ADHD in patients 6 years and above.
IMPORTANT SAFETY INFORMATION
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.
- Do not take Vyvanse if you or your child:
- 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
- Some people have had the following problems when taking stimulant medicines, such as Vyvanse:
1. Heart-related problems including:
- 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 (lisdexamfetamine dimesylate).
3. Circulation problems in fingers and toes [Peripheral vasculopathy,
including Raynaud’s phenomenon]:
- Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red
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.
- Tell the doctor if you or your child is pregnant, breast-feeding, or plans to become pregnant or breast-feed.
- Vyvanse may cause serious side effects, including:
- slowing of growth (height and weight) in children. Your child should have his or her height and weight checked often while taking Vyvanse. The doctor may stop treatment if a problem is found during these check-ups.
- The most common side effects reported in studies of Vyvanse were:
- anxiety
- decreased appetite
- diarrhea
- dizziness
- dry mouth
- irritability
- loss of appetite
- nausea
- trouble sleeping
- upper stomach pain
- vomiting
- weight loss
For additional safety information, click here forPrescribing Information andMedication Guide.
NOTES TO EDITORS
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 focus on providing treatments in Neuroscience, Rare Diseases, and Gastrointestinal and Internal Medicine and are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmology.
SOURCE: Shire
