Tous Actualités
Suivre
Abonner Shire Pharmaceuticals Group Plc

Shire Pharmaceuticals Group Plc

Shire Announces Update to Vyvanse® (lisdexamfetamine dimesylate) U.S. Labeling to Include New Longer-Term Maintenance of Efficacy Data in Adults with Moderate to Severe Binge Eating Disorder

Massachusetts (ots/PRNewswire)

Labeling Update Based on Maintenance of Efficacy Data from a 38-Week Phase 3 Study

For U.S. Audiences Only - Shire plc (LSE: SHP, NASDAQ: SHPG) announces an update to the Vyvanse® (lisdexamfetamine dimesylate) labeling to include information regarding the approval of a supplemental New Drug Application (sNDA) by the U.S. Food and Drug Administration (FDA). The labeling will now include maintenance of efficacy data from SPD489-346, the first-ever longer-term pharmacologic study (38 weeks) in adults with moderate to severe binge eating disorder (B.E.D.). Results from SPD489-346, which were announced in July 2015, indicated that Vyvanse (n=136) demonstrated significant maintenance of efficacy compared to placebo (n=131) based upon the primary endpoint of time to relapse (p<0.001). Vyvanse is approved in the U.S. for adults with moderate to severe B.E.D. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

"The FDA approval for the labeling update to include maintenance of efficacy data from the first-ever longer-term pharmacologic study in adults with moderate to severe B.E.D. advances our understanding of the efficacy and safety profile of Vyvanse for adults living with the disorder," said Philip J. Vickers, Ph.D., Global Head of Research and Development at Shire. "Collectively, the data and labeling update represent Shire's commitment to supporting patients and the health care community by expanding the growing body of research on B.E.D. with longer-term data in this disorder."

In the 26-week, double-blind, placebo-controlled, randomized-withdrawal phase of this study, relapse was defined as having two or more binge days per week for two consecutive weeks prior to any visit and an increase in Clinical Global Impressions-Severity (CGI-S) score of two or more points relative to the randomized-withdrawal baseline visit. At the conclusion of the study, maintenance of efficacy for patients who had an initial response to Vyvanse during the open-label treatment phase, and then continued on Vyvanse during the randomized-withdrawal phase, was demonstrated with Vyvanse being superior over placebo as measured by time to relapse. The safety profile for Vyvanse in this study, which evaluated treatment-emergent adverse events (TEAEs) and vital signs, was generally consistent with the known profile reported in previous studies in adult patients with moderate to severe B.E.D.

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law.

"These data help health care professionals make more informed decisions when discussing treatment options for B.E.D. in adults," said Susan L. McElroy, M.D., Professor of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine. "Further, the updated Vyvanse labeling with this longer-term maintenance of efficacy data will offer health care professionals a better understanding of how the medication may be incorporated into broader treatment plans for adults with moderate to severe B.E.D."

Vyvanse is not appropriate for all adults with moderate to severe B.E.D. Adult patients who think they may have symptoms of B.E.D. should talk to their health care professional (HCP). Patients should work with their HCP to develop an appropriate treatment plan.

About The Study

Study SPD489-346

This Phase 3, 38-week, multi-center, double-blind, placebo-controlled, randomized-withdrawal study evaluated the maintenance of efficacy between dose-optimized Vyvanse and placebo based on the primary endpoint of time to relapse in adults aged 18 to 55 (N=267) with moderate to severe B.E.D. A diagnosis of B.E.D. was based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR®) criteria.

The study consisted of a four-week screening period and a 12-week open-label treatment phase, followed by a 26-week, double-blind, placebo-controlled, randomized-withdrawal phase. During the four-week dose-optimization period, all patients were initiated on Vyvanse 30 mg per day, and then titrated weekly in 20 mg increments to their optimal dose (either 50 mg or 70 mg per day). Patients who met response criteria (one or fewer binge days each week for four consecutive weeks prior to the last visit and had a CGI-S score of two or less at the same visit) at the end of the 12-week open-label phase were randomized to Vyvanse or placebo treatment groups. During this 26-week randomized-withdrawal phase, patients either continued with the same optimized dose of Vyvanse (n=136) from the open-label phase or were switched to placebo (n=131). The primary endpoint was defined as the time to relapse from randomization. Relapse was defined as having two or more binge days per week for two consecutive weeks prior to any visit and an increase in CGI-S score of two or more points relative to the randomized-withdrawal baseline visit. Vyvanse demonstrated superiority over placebo based on the primary endpoint of time to relapse.

The safety profile for Vyvanse in this study, which evaluated TEAEs and vital signs, was generally consistent with the known profile reported in previous studies in adult patients with moderate to severe B.E.D.

During the open-label phase (N=411), three patients experienced serious adverse events (SAEs) and 22 patients reported TEAEs that led to study discontinuation. The most commonly reported TEAEs (reported in 5 percent or more of patients) included dry mouth, headache, insomnia, decreased appetite, nausea, anxiety, constipation, hyperhidrosis, feeling jittery, and diarrhea.

During the randomized-withdrawal phase (Vyvanse, n=136; Placebo, n=134), two patients treated with Vyvanse experienced SAEs and six patients on Vyvanse reported TEAEs that led to study discontinuation. The most commonly reported TEAEs (reported in 5 percent or more of patients) in patients taking Vyvanse included nasopharyngitis, headache, upper respiratory tract infection, and dry mouth, and in patients taking placebo included nasopharyngitis, headache, and fatigue.

About B.E.D.

Binge eating disorder (B.E.D.), recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5®) as a distinct eating disorder in 2013, is defined as recurring episodes (on average, at least once weekly, for three months) of consuming an unusually large amount of food in a short time, compared with what others would consume under the same or similar circumstances. Adults with B.E.D. feel a sense of lack of control over eating during a binge eating episode and marked distress over their binge eating episodes. They typically experience shame and guilt about their binge eating, among other symptoms, and may conceal their eating problems. Unlike people with other eating disorders, adults with B.E.D. don't routinely try to "undo" their excessive eating with extreme actions like purging or over-exercising. Only a doctor or other qualified HCP can diagnose B.E.D. and determine an appropriate treatment plan.

B.E.D. is the most common eating disorder among U.S. adults, and is more common than anorexia nervosa and bulimia nervosa combined. The disorder occurs in both men and women, is seen across racial and ethnic groups in U.S. adults, and can occur in normal weight, overweight, and obese adults.

About Vyvanse® (lisdexamfetamine dimesylate)

What is Vyvanse?

Vyvanse is a prescription medicine used for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity.

IMPORTANT SAFETY INFORMATION

Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law.

Vyvanse is a stimulant medicine. Tell the doctor if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Who should not take Vyvanse?

Do not take Vyvanse if you are:

- taking or have taken an anti-depression medicine called a monoamine
  oxidase inhibitor (MAOI) within the past 14 days
- sensitive or allergic to, or had a reaction to other stimulant 
  medicines

Problems that can occur while taking Vyvanse. Tell the doctor if you:

- have heart problems or heart defects, high blood pressure, or a 
  family history of these problems. This is important because sudden 
  death has occurred in people with heart problems or defects who 
  were taking stimulant medicines, and sudden death, stroke and heart
  attack have happened in adults taking stimulant medicines. Since 
  increases in blood pressure and heart rate may occur, the doctor 
  should regularly check these during treatment. Call the doctor 
  right away if you have any signs of heart problems such as chest 
  pain, shortness of breath, or fainting while taking Vyvanse.
- have mental problems, or a family history of suicide, bipolar 
  illness, or depression. This is important because new or worsening 
  behavior and thought problems or bipolar illness may occur. New 
  symptoms such as seeing or hearing things that are not real, 
  believing things that are not true, being suspicious, or having new
  manic symptoms may occur. Call the doctor right away if there are 
  any new or worsening mental symptoms during treatment.
- have 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 the doctor right away if any
  signs of unexplained wounds appear on fingers or toes while taking 
  Vyvanse.
- are pregnant or plan to become pregnant. It is not known if Vyvanse
  may harm your unborn baby. Are breastfeeding or plan to breastfeed.
  Do not breastfeed while taking Vyvanse. Talk to your doctor about 
  the best way to feed your baby if you take Vyvanse.

What are possible side effects of Vyvanse?

The most common side effects of Vyvanse reported in studies of adults with moderate to severe B.E.D. include:



· dry mouth            · constipation
· trouble sleeping     · feeling jittery
· decreased appetite

· increased heart rate · anxiety

For additional safety information, click here for Prescribing Information (http://pi.shirecontent.com/PI/PDFs/Vyvanse_USA_ENG.pdf) and Medication Guide (http://medguide.shirecontent.com/MEDGUIDE/PDFs/MG_Vyvanse_USA_ENG.pdf) and discuss with your doctor.

Vyvanse® is a registered trademark of Shire LLC. Vyvanse is available in 10, 20, 30, 40, 50, 60, and 70 mg capsules.

DSM-IV-TR® and DSM-5® are registered trademarks of the American Psychiatric Association.

NOTES TO EDITORS

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.

http://www.shire.com

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.

Contact:

please contact:

Investor Relations
Sarah Elton-Farr, seltonfarr@shire.com, +44-1256-894157
Ian Karp, ikarp@shire.com, +1-781-482-9018
Robert Coates, rcoates@shire.com, +44-1256-894874

Media
Gwen Fisher, gfisher@shire.com, +1-484-595-9836
Clotilde Houzé, chouze0@shire.com, +1-781-266-3567

Plus de actualités: Shire Pharmaceuticals Group Plc
Plus de actualités: Shire Pharmaceuticals Group Plc