FDA Approves Mydayis

Lexington, Mass., USA – June 20, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved Mydayis (mixed salts of a single-entity amphetamine product), a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD). Mydayis is not for use in children 12 years and younger. Shire expects to make Mydayis commercially available in the United States in the third quarter of 2017.

The U.S. FDA approval of Mydayis is based on results from 16 clinical studies evaluating Mydayis in more than 1,600 subjects, including adolescents (aged 13 to 17 years) and adults with ADHD. In pivotal, placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP, an objective, validated, skill-adjusted math test that measures attention in ADHD patients, reached statistical significance beginning at 2 or 4 hours post-dose and lasting up to 16 hours post-dose.“Mydayis is the latest innovation in Shire’s 20-year legacy of helping to support the treatment of ADHD. It’s a testament to Shire’s commitment to helping support the evolving needs of appropriate patients with ADHD,” said Flemming Ornskov, M.D., MPH, CEO of Shire. “With this approval, we hope to help patients who need a once-daily treatment option. Mydayis has shown efficacy lasting up to 16 hours after taking one capsule, beginning at 2 or 4 hours post-dose.”

Andrew J. Cutler, M.D., Executive Vice President and Chief Medical Officer at Meridien Research and an investigator in the Mydayis clinical trials said: “Many of my patients living with ADHD are trying to manage symptoms that impact them in different settings – often across home life, school or work, and in social settings. Patients have individual needs and may respond differently to treatments, so it is important for healthcare professionals to have multiple options. It’s rewarding to work with Shire to provide a new treatment option that may help appropriate patients with ADHD.”

Mydayis, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mydayis.

In pivotal Phase 3 clinical studies where efficacy was the primary endpoint, a morning dose of Mydayis demonstrated superiority to placebo based on the change from baseline in the ADHD-RS-IV total score for adult and adolescent patients, respectively. The most common adverse reactions associated with Mydayis (incidence ≥5% and at a rate at least twice placebo) in adults are insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety. For pediatric patients (13 years and older), the most common adverse reactions were insomnia, decreased appetite, decreased weight, irritability, and nausea.

In Phase 2 studies (two studies in adults and one in adolescents), patients treated with Mydayis demonstrated improved attention compared to placebo, as assessed by the total PERMP score, with results reaching statistical significance beginning at 2 or 4 hours post-dose, and lasting up to 16 hours post-dose. Across all clinical studies, adverse events were generally mild to moderate in severity and similar to those observed with other amphetamine compounds.

ADHD is a neurodevelopmental disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. An estimated 4.4% 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. Approximately 50 to 66% of children with ADHD may continue to have ADHD symptoms as adults. Medication is not appropriate for all individuals diagnosed with ADHD.

“Being diagnosed with ADHD as an adult helped me understand my symptoms,” said Gina D’Angelo, an adult patient with ADHD. “Living with my ADHD symptoms is an ongoing process, and how I navigate my daily responsibilities with ADHD changes as I learn more about it. It is encouraging to see new options that may help adults manage their ADHD symptoms.”

What is Mydayis?

Mydayis is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. Mydayis is not for use in children 12 years and younger.

IMPORTANT SAFETY INFORMATION

Abuse and dependence. Mydayis, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mydayis.

• Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
• Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

Who should not take Mydayis?

Do not take Mydayis if you or your child is:

• allergic to amphetamine or any of the ingredients in Mydayis. See the end of the Medication Guide for a complete list of ingredients in Mydayis.

Problems that can occur while taking Mydayis. Tell your doctor:

• if you or your child have any heart problems, 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 taking stimulant medicines, and sudden death, stroke and heart attack have happened in adults taking stimulant medicines. Your healthcare provider should check you or your child carefully for heart problems before starting Mydayis. Since increases in blood pressure and heart rate may occur, your healthcare provider should regularly check these during treatment. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Mydayis.
• if you or your child have mental (psychiatric) problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worse behavior and thought problems or new or worse bipolar illness may occur. New symptoms such as hearing voices, seeing or believing things that are not real, or new manic symptoms may occur. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
• if your child is having slowing of growth (height and weight); Mydayis may cause this serious side effect. Your child should have height and weight checked often while taking Mydayis. Your healthcare provider may stop treatment if a problem is found during these check-ups.
• if you or your child 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. Tell your healthcare provider if you or your child have any numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Call your healthcare provider if you or your child have any signs of unexplained wounds appearing on fingers or toes while taking Mydayis.
• if you have a seizure. Your healthcare provider will stop treatment.
• if you have symptoms of serotonin syndrome such as agitation, hallucinations, coma, or other changes in mental status; problems controlling your movements or muscle twitching; fast heartbeat; sweating or fever; nausea, vomiting or diarrhea; or muscle stiffness or tightness. Call your healthcare provider or go to the nearest hospital emergency room if you have these symptoms. Serotonin syndrome may happen when Mydayis is taken with certain other medicines and may be life-threatening.
• if you or your child are pregnant or plan to become pregnant. It is not known if Mydayis may harm your unborn baby.
• if you or your child are breastfeeding or plan to breastfeed. You should not breastfeed while taking Mydayis. Mydayis passes into breast milk.

What are possible side effects of Mydayis?

The most common side effects of Mydayis include:

• trouble sleeping
• decreased appetite,
• dry mouth
• increased heart rate
• anxiety
• nausea
• irritability
• weight loss

For additional safety information, click here for Prescribing Information, including Medication Guide and Warning about Abuse, and discuss with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.