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WOODCLIFF LAKE, N.J., September 28, 2018 / PRNewswire / – Eisai Inc. announced today that the United States Food and Drug Administration (FDA) has expanded the indication of its antiepileptic drug FYCOMPA® (perampanel) CIII monotherapy and combination therapy in pediatric patients 4 years of age and older for the treatment of partial onset seizures, with or without secondary generalized seizures. The approval includes both FYCOMPA oral tablet and suspension formulations.
"Eisai is working tirelessly to provide treatment options to patients of all ages to better control seizures and achieve the ultimate goal of crisis release," said Lynn Kramer, MD, Head of Clinic 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 in pediatric patients with epilepsy.This step underscores our commitment to providing treatment options to children with epilepsy for which there is still an unmet need. "
Today, an estimated 470,000 children in the United States live with epilepsy. Up to 40 percent will not reach the freedom of seizure in the presence of an existing treatment and will face uncontrolled crises.
"Taking an AED as prescribed daily is an essential part of achieving the goal of freeing pediatric patient seizures," said Jesus Eric Piña-Garza, MD, Pediatric Neurologist, Tri-Star Medical Group, Childhood specialist in the child. "With FYCOMPA, kids and their parents now have a unique dosing option a day with a long half-life that can fit into their increasingly busy lives."
Some patients may also have seizures, which occur in people who have already achieved reliable control of seizures. Seizures can be caused by any number of factors, including illness and sleep loss. The doses of forgotten drugs are the first cause of seizures. FYCOMPA has a long half-life and during a pharmacokinetic study it has been shown that in case of missed dose, plasma concentrations remain relatively stable.
The use of FYCOMPA for the treatment of partial seizures in adolescents and children aged 4 to less than 12 years with epilepsy is supported by extrapolated efficacy from three adequate phase 3 studies and well controlled on FYCOMPA in adult patients with POS. The safety was evaluated in two studies in pediatric patients with epilepsy aged from 4 to less than 12 years old. A total of 225 patients received FYCOMPA, including 110 patients exposed for at least 6 months and 21 patients for at least 1 year. Adverse events observed in children aged 4 to 12 years were similar to those seen in patients 12 years of age and older.
The end results of these studies supporting FDA approval in pediatric patients 4 years of age and older will be presented at an upcoming medical meeting.
FYCOMPA was initially approved for adjunctive use in outlets in 2012, and was approved as an adjunctive therapy for seizures with TPCG in patients with epilepsy 12 years of age and older, then monotherapy for outlets with or without secondary generalized secondary seizures in patients with epilepsy 12. years and older. To date, FYCOMPA is approved in 55 countries and has treated more than 200,000 patients worldwide in 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 affecting approximately 3.4 million people United States, including 470,000 children. Children with uncontrolled seizures run a greater risk of unexpected sudden death in epilepsy (SUDEP), which is relatively rare in childhood, but the risk increases if epilepsy persists in the future. Adulthood.
Partial seizures are the most common type of seizure in people with epilepsy, accounting for 60% of all seizures. Seizures account for up to 25% of all epileptic seizures, with generalized primary tonic-clonic seizures being one of the most common and severe forms of seizures.
Missed drug doses are the leading cause of seizures, which can cause serious injury to patients. People who experience epileptic seizures have an increased risk of fractures or head injuries, emergency visits and hospitalization, as well as an associated increase in health care costs.
About FYCOMPA
FYCOMPA is a prescription medication used in people with epilepsy aged 4 years and older, alone or in combination with other drugs to treat partial-onset seizures, with or without secondary generalized seizures, and other drugs to treat the primary generalized tonic-clonic seizures of people with 12-year-old epilepsy. and older.
FYCOMPA, a unique oral drug, is a selective and non-competitive AMPA receptor antagonist (alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid). The precise mechanism by which FYCOMPA exerts its antiepileptic effects in humans is unknown. In a pharmacokinetic study, it was shown that because of its long half-life, a missed dose of FYCOMPA has no significant impact on plasma concentrations.
FYCOMPA is available as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets and 0.5 mg / mL oral suspension. FYCOMPA has been designated by the US 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 medication used:
- alone or with other drugs to treat partial seizures with or without generalized secondary seizures in people with epilepsy aged 4 years and over
- with other drugs to treat primary generalized tonic-clonic seizures in people with epilepsy aged 12 and over
It is not known whether FYCOMPA is safe and effective for partial seizures in children under 4 years of age or for primary generalized tonic-clonic seizures in patients younger than 12 years of age.
Important safety information
What is the most important information I should know about FYCOMPA?
1. FYCOMPA can cause mental (psychiatric) problems, including:
- aggressive behavior new or worse (including homicidal behavior), hostility, anger, anxiety or irritability
- be suspicious or suspicious (believe in things that are not true)
- see objects or hear things that are not there
- confusion
- difficulty with memory
- Other unusual or extreme changes in behavior or mood: Tell your health care provider immediately if you have any new mental problems or worsening of your mental problems while you are taking FYCOMPA.
2. Like other antiepileptic drugs, FYCOMPA can cause thoughts or suicidal actions in a very small number of people, about 1 in 500 people. Call your health care provider immediately if you have any of these symptoms, especially if they are a new, worse or worrying disease. :
- thoughts about suicide or death
- new depression or worse
- feeling restless or agitated
- sleep disorders (insomnia)
- acting aggressive, angry or violent
- an extreme increase in activity and speech (mania)
- suicide attempt
- anxiety new or worse
- panic attacks
- irritability new or worse
- act on dangerous impulses
- other unusual changes in behavior or mood
Suicidal thoughts or actions can be caused by things other than drugs. If you have thoughts or suicidal acts, your health care provider may look for other causes.
How can I monitor the first symptoms of suicidal ideation and action?
- Pay attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings
- Keep all follow-up visits with your health care provider as planned
Call your health care provider between visits as needed, especially if you fear symptoms.
Do not stop FYCOMPA without first talking to your health care provider. A sudden stop can cause serious problems and can lead to seizures more often.
Before taking FYCOMPA, tell your healthcare professional about all your medical conditions, including if you:
- you have or have had depression, mood problems, aggressive or hostile behavior (eg, homicidal behavior), suicidal thoughts or behaviors, or other psychiatric problems
- have liver or kidney problems
- drink alcohol
- Has already abused prescription drugs, illegal drugs or alcohol
- Are pregnant or planning 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 professional about your North American antiepileptic pregnancy registration (1-888-233-2334).
- breastfeed or plan to breastfeed. If you are taking FYCOMPA, talk to your health care provider about the best way to feed your baby and decide whether to take FYCOMPA or breastfeed. You should not do both.
Tell your health care provider about all the medications you are taking, including prescription and over-the-counter medications, vitamins, and herbal supplements. Taking FYCOMPA with certain other medicines may cause side effects or reduce the benefits of one or the other medication. These medications include: birth control, carbamazepine, phenytoin, oxcarbazepine, rifampin and St. John's wort.
What should I avoid while taking FYCOMPA?
Do not drive, use heavy machinery, or do other dangerous activities until you know how FYCOMPA affects you. FYCOMPA can make you dizzy, sleepy or tired. Do not drink alcohol or take any other medicines that make you sleepy or dizzy until you talk to your healthcare professional. FYCOMPA taken with alcohol or drugs causing drowsiness or dizziness may worsen your drowsiness or dizziness. When it is taken with alcohol, FYCOMPA can also aggravate your mood, 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 rotation) and difficulty walking normally. You may have difficulty walking normally if you are unstable because you feel dizzy. These symptoms may increase when your dose of FYCOMPA is increased. Your risk of feeling dizzy and having trouble walking normally may be higher if you are a senior.
- Drowsiness and fatigue
- Increased risk of falls. Taking FYCOMPA can increase your chances of falling. These falls can cause serious injury. Your risk of falling may be higher if you are older.
- A severe allergic reaction that can 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 lead to death. Call your health professional immediately if you have:
- 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
- feel like sleeping
- tired
- irritability
- falls
- nausea and vomiting
- weight gain
- vertigo (sense of rotation)
- problems to walk normally
- muscular coordination problems
- headache
- bruising
- abdominal pain
- anxiety
FYCOMPA is a controlled substance (CIII) because it can be abused or lead to addiction. Keep FYCOMPA in a safe place to protect it from theft and never give it to anyone as it could be harmful. Selling or giving FYCOMPA is illegal.
You are encouraged to report the negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please refer to the complete prescription information for FYCOMPA (perampanel), including the boxed WARNING.
Sure Eisai Inc.
At Eisai Inc., human health care (hhc) is our goal. We give our first thoughts to patients and their families, and help increase the benefits of health care. As a US pharmaceutical subsidiary of Eisai Co., Ltd. Based in Tokyo, we have a passionate commitment to patient care, which is the driving force behind our efforts to discover and develop innovative therapies to address unmet medical needs.
Eisai is a fully integrated pharmaceutical company operating in two global groups: Oncology and Neurology (dementia and neurodegenerative diseases). Each group operates as an end-to-end global enterprise with discovery, development and marketing capabilities. Our US 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., visit www.eisai.com/US and follow us on Twitter and LinkedIn.
Contact:
Media requests
Michele Randazzo
Eisai Inc.
201-746-2979
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SOURCE Eisai Inc.
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