- First antiepileptic drug (AED) to apply FDA’s regulatory pathway of extrapolation for monotherapy use; FDA proposed using this pathway to get monotherapy options to patients sooner
- FYCOMPA has now treated more than 100,000 patients worldwide across different indications and formulations
- Once-a-day FYCOMPA is the first and only AED to target the AMPA receptor
Woodcliff Lake, NJ, July 26, 2017 – Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) for FYCOMPA® (perampanel) CIII as monotherapy use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. In addition to the new monotherapy use in POS, FYCOMPA is approved for adjunctive use for POS and primary generalized tonic-clonic seizures (PGTC) in patients with epilepsy 12 years of age and older.
FYCOMPA is the first AED approved by the FDA following the pathway outlined in the agency’s September 13, 2016 General Advice Letter to AED NDA holders stating “it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial onset seizures (POS) to their use as monotherapy for the treatment of POS.” FYCOMPA’s approval for monotherapy use has been extrapolated based on comparable exposures to those obtained with adjunctive use in clinical trials for the treatment of partial-onset seizures.
“This approval is good news for the epilepsy community because it means that more physicians and patients will have access to a single agent option for partial-onset seizures,” said Jacqueline A. French, MD, Professor of Neurology in the Epilepsy division at NYU Langone Medical Center, Chief Scientific Officer for the Epilepsy Foundation and Director of the Epilepsy Study Consortium, a nonprofit organization devoted to speeding new therapies through the development process and into the clinic. “To date, conducting clinical trials with single agents in epilepsy has been problematic. Now, with this change in the regulatory pathway, we have a safe and efficient process for quicker access to single agent therapies for partial-onset seizures.”
“Approximately one-third of people living with epilepsy have seizures that are not adequately controlled,” said Robert Wechsler, MD, PhD, Medical Director, Idaho Comprehensive Epilepsy Center. “Having a new monotherapy option for partial-onset seizures that is once-a-day gives physicians and patients an effective treatment option that has the potential to make a difference in patients’ lives.”
FYCOMPA was initially approved for adjunctive use in POS in 2012 and has been approved in 55 countries worldwide. To date, more than 100,000 patients have been treated with FYCOMPA. An oral suspension formulation was also approved in 2016. In the three initial adjunctive pivotal clinical trials in patients with partial-onset seizures, results showed improvement in seizure control in patients taking FYCOMPA compared with those taking placebo.
“We are proud to be the first company to receive an approval for monotherapy use in partial-onset seizures following the FDA regulatory pathway of extrapolation that was based on the agency’s careful review of existing data generated in monotherapy and adjunctive therapy trials,” said Lynn Kramer, MD, Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. “This effort is consistent with Eisai’s broader mission of addressing the unmet needs of patients and making sure our therapies are available to those who need them in a timely manner.”
Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. According to the Institute of Medicine, epilepsy is one of the most common neurological disorders, which affects about 2.9 million people in the United States. Partial-onset seizures are the most common type of seizure seen in people with epilepsy, accounting for 60 percent of all seizures.
FYCOMPA is a once-daily prescription medicine used in people with epilepsy aged 12 and older:
· alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures
· with other medicines to treat primary generalized tonic-clonic seizures
FYCOMPA is a unique oral medication and 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.
FYCOMPA is supplied as 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg film-coated tablets, and in an 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.
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
· difficulty with memory
· other unusual or extreme changes in behavior or mood
Tell 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 a 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||· attempt to commit suicide|
|· new or worse depression||· new or worse anxiety|
|· feeling agitated or restless||· panic attacks|
|· trouble sleeping (insomnia)||· new or worse irritability|
|· acting aggressive, being angry, or violent||· acting on dangerous impulses|
|· an extreme increase in activity and talking (mania)||· 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 a 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, 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:
o a skin rash, hives
o fever or swollen glands that do not go away
o swelling of your face
o 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||· nausea and vomiting||· headache|
|· sleepiness||· weight gain||· bruising|
|· tiredness||· vertigo (sense of spinning)||· abdominal pain|
|· irritability||· problems walking normally||· anxiety|
|· falls||· problems with muscle coordination|
FYCOMPA is a controlled substance (CIII) because it can be abused or lead to drug dependence. Keep your 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 call1-800-FDA-1088.
Please see Full Prescribing Information.
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.