Eisai Announces FDA Approval Of FYCOMPA® in Pediatric Patients As Young As 4 Years Old For The Treatment Of Partial-Onset Seizures

WOODCLIFF LAKE, N.J., Sept. 28, 2018 /PRNewswire/ -- Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug FYCOMPA^® (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures. The approval includes both FYCOMPA tablet and oral suspension formulations.

"Eisai is working tirelessly to provide treatment options for patients of all ages to help better control seizures and achieve the ultimate goal of seizure freedom," said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. "We are excited about the potential of FYCOMPA as an important tool to reduce the incidence of seizures among pediatric patients living with epilepsy. This milestone underscores our commitment to providing treatment options for children with epilepsy for whom there is still a significant unmet need."

Today, an estimated 470,000 children in the U.S. are living with epilepsy. Up to 40 percent will not achieve seizure freedom with existing treatment and will struggle with uncontrolled seizures.

"Taking an AED as prescribed every day is a critical part of reaching the goal of seizure freedom for pediatric patients," said Jesus Eric Piña-Garza, MD, pediatric neurologist, Tri-Star Medical Group Children's Specialists. "With FYCOMPA, children and their parents now have a once-daily dosing option with a long half-life that can fit into their increasingly busy lives."

Some patients may also experience breakthrough seizures, which occur in individuals who have previously achieved reliable seizure control. Breakthrough seizures can be caused by any number of factors including illness and loss of sleep. Missed medication doses are the number one cause of breakthrough seizures. FYCOMPA has a long half-life and in a pharmacokinetic study, it has been demonstrated that in the event of a missed dose, plasma levels remain relatively stable.

The use of FYCOMPA for the treatment of partial-onset seizures in adolescents and children 4 to <12 years with epilepsy is supported by efficacy extrapolated from three Phase 3 adequate and well-controlled studies of FYCOMPA in adult patients with POS. Safety was evaluated in two studies in pediatric patients 4 to <12 years of age with epilepsy, a total of 225 patients received FYCOMPA, with 110 patients exposed for at least 6 months, and 21 patients for at least 1 year. Adverse reactions in pediatric patients 4 to <12 years of age were similar to those seen in patients 12 years of age and older.

Final results of these studies supporting the FDA approval in pediatric patients 4 years and older will be presented at an upcoming medical meeting.

FYCOMPA was initially approved for adjunctive use in POS in 2012, and was later approved as adjunctive therapy for PGTC seizures in patients with epilepsy 12 years of age and older, and then as monotherapy for POS with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. To date, FYCOMPA is approved in 55 countries and has treated more than 200,000 patients worldwide across all indications.

About Epilepsy

Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Epilepsy is one of the most common neurological disorders, which affects about 3.4 million people in the United States, including 470,000 children. Children with uncontrolled seizures are at greater risk for sudden unexpected death in epilepsy (SUDEP), which is relatively uncommon in childhood, but the risk increases if epilepsy persists into adulthood.

Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60 percent of all seizures. Convulsive seizures account for up to 25 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of seizures.

Missed medication doses are the number one cause of breakthrough seizures, which can cause significant injury to patients. People who experience breakthrough seizures have an increased risk of fractures or head injuries, emergency room (ER) visits, and hospitalization, as well as an associated increase in healthcare costs.

About FYCOMPA
FYCOMPA is a prescription medicine used in people with epilepsy aged 4 and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures, and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older.

FYCOMPA, a unique oral medication, is a selective, non-competitive AMPA (alpha-amino-3-hydroxy-5- methyl-4-isoxazolepropionic acid) receptor antagonist. The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans is unknown. In a pharmacokinetic study, it has been demonstrated that because of its long half-life, a missed dose of FYCOMPA does not significantly impact plasma levels.

FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets, and as a 0.5 mg/mL oral suspension formulation. FYCOMPA has been designated by the U.S. Drug Enforcement Administration as a federally-controlled substance (CIII).

Please visit www.FYCOMPA.com to learn more about the treatment.

What is FYCOMPA® (perampanel)?

FYCOMPA is a prescription medicine used:

• alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures in people with epilepsy aged 4 and older
• with other medicines to treat primary generalized tonic-clonic seizures in people with epilepsy aged 12 and older

It is not known if FYCOMPA is safe and effective for partial-onset seizures in children under 4 years of age or for primary generalized tonic-clonic seizures in patients under 12 years of age.

Important Safety Information

What is the most important information I should know about FYCOMPA?
1. FYCOMPA may cause mental (psychiatric) problems, including:

• new or worse aggressive behavior (including homicidal behavior), hostility, anger, anxiety, or irritability
• being suspicious or distrustful (believing things that are not true)
• seeing objects or hearing things that are not there
• confusion
• difficulty with memory
• other unusual or extreme changes in behavior or moodTell your healthcare provider right away if you have any new or worsening mental problems while taking FYCOMPA.

2. Like other antiepileptic drugs, FYCOMPA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.  Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• new or worse depression  
• feeling agitated or restless
• trouble sleeping (insomnia)
• acting aggressive, being angry, or violent
• an extreme increase in activity and talking (mania)
• attempt to commit suicide
• new or worse anxiety
• panic attacks
• new or worse irritability
• acting on dangerous impulses
• other unusual changes in behavior or mood

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

• Pay attention to any changes especially sudden changes in mood, behaviors, thoughts, or feelings
• Keep all follow-up visits with your healthcare provider as scheduled

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop FYCOMPA without first talking with your healthcare provider. Stopping suddenly can cause serious problems and can cause you to have seizures more often.

Before taking FYCOMPA, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had depression, mood problems, aggressive or hostile behavior (for example, homicidal behavior), suicidal thoughts or behavior, or other psychiatric problems
• have liver or kidney problems
• drink alcohol
• have abused prescription medicines, street drugs, or alcohol in the past
• are pregnant or plan to become pregnant. It is not known if FYCOMPA will harm your unborn baby. If you become pregnant while taking FYCOMPA, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry (1-888-233-2334)
• are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you take FYCOMPA and to decide if you will take FYCOMPA or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking FYCOMPA with certain other medicines can cause side effects or reduce either drug's benefit. These medicines include: birth control, carbamazepine, phenytoin, oxcarbazepine, rifampin, and St. John's Wort.

What should I avoid while taking FYCOMPA?
Do not drive, operate heavy machinery, or do other dangerous activities until you know how FYCOMPA affects you. FYCOMPA may make you dizzy, sleepy, or tired. Do not drink alcohol or take other medicines that make you sleepy or dizzy until you talk to your healthcare provider. FYCOMPA taken with alcohol or medicines that cause sleepiness or dizziness may make your sleepiness or dizziness worse. FYCOMPA when taken with alcohol may also make your mood worse, increase anger, confusion, and depression.

What are the possible side effects of FYCOMPA?
FYCOMPA may cause other serious side effects, including:

• Dizziness, vertigo (sense of spinning), and problems walking normally. You may have problems walking normally if you are unsteady because you feel dizzy. These symptoms can increase when your dose of FYCOMPA is increased. Your risk of feeling dizzy and having problems walking normally may be higher if you are elderly.
• Sleepiness and tiredness
• Increased risk of falls. Taking FYCOMPA can increase your chance of falling. These falls can cause serious injuries. Your risk of falling may be higher if you are elderly.
• A serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death. Call your healthcare provider right away if you have:
• a skin rash, hives
• fever or swollen glands that do not go away
• swelling of your face
• shortness of breath, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine

The most common side effects of FYCOMPA include:

• dizziness
• sleepiness
• tiredness
• irritability
• falls
• nausea and vomiting
• weight gain
• vertigo (sense of spinning)
• problems walking normally
• problems with muscle coordination
• headache
• bruising
• abdominal pain
• anxiety

FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Keep FYCOMPA in a safe place to protect it from theft and never give it to anyone else because it may harm them. Selling or giving away FYCOMPA is against the law.

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.

Please see accompanying Full Prescribing Information for FYCOMPA (perampanel), including Boxed WARNING.

About Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to discover and develop innovative therapies to help address unmet medical needs.

Eisai is a fully integrated pharmaceutical business that operates in two global business groups: oncology and neurology (dementia-related diseases and neurodegenerative diseases). Each group functions as an end-to-end global business with discovery, development, and marketing capabilities. Our U.S. headquarters, commercial and clinical development organizations are located in New Jersey; our discovery labs are in Massachusetts and Pennsylvania; and our global demand chain organization resides in Maryland and North Carolina. To learn more about Eisai Inc., please visit us at www.eisai.com/US and follow us on Twitter and LinkedIn.

Contact:

Media Inquiries
Michele Randazzo
Eisai Inc.
201-746-2979

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