Application Based on New FDA Communication Supporting Use as Monotherapy for the Treatment of Partial Onset Seizures Based on Extrapolation
WOODCLIFF LAKE, NJ, USA I September 26, 2016 I Eisai Inc. announced today that it has submitted a supplemental application to the U.S. Food and Drug Administration (FDA) for a proposed label change for its antiepileptic drug FYCOMPA® (perampanel) CIII which would include use as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.
FYCOMPA is approved as an adjunctive therapy, or an add-on treatment, in combination with another antiepileptic drug (AED), for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. Please see Important Safety Information for FYCOMPA, including Boxed WARNING for Serious Psychiatric and Behavioral Reactions, below.
Eisai submitted its application based on a new FDA communication which states that 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” as long as adequate information is provided on pharmacokinetics and possible drug-drug interactions (inhibition or induction) that may alter the metabolism of the drug. Eisai has submitted such data along with the proposed new label.
“Eisai is pleased to submit this new application, which may lead to an additional treatment option for those suffering from partial onset seizures,” said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. “As a company, we are committed to advancing treatments that will make a difference to those who are affected by epilepsy, and we’re looking forward to the potential for FYCOMPA as a single agent to help more patients suffering from these types of seizures.”
This release discusses a non-approved use for FYCOMPA. It is not intended to convey conclusions about efficacy or safety for such use. There is no guarantee that the proposed use discussed in this release will gain FDA approval.
About Epilepsy
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 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. Generalized seizures account for approximately 40 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of generalized seizures.
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.
SOURCE: Eisai
Post Views: 184
Application Based on New FDA Communication Supporting Use as Monotherapy for the Treatment of Partial Onset Seizures Based on Extrapolation
WOODCLIFF LAKE, NJ, USA I September 26, 2016 I Eisai Inc. announced today that it has submitted a supplemental application to the U.S. Food and Drug Administration (FDA) for a proposed label change for its antiepileptic drug FYCOMPA® (perampanel) CIII which would include use as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older.
FYCOMPA is approved as an adjunctive therapy, or an add-on treatment, in combination with another antiepileptic drug (AED), for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures, and primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy 12 years of age and older. Please see Important Safety Information for FYCOMPA, including Boxed WARNING for Serious Psychiatric and Behavioral Reactions, below.
Eisai submitted its application based on a new FDA communication which states that 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” as long as adequate information is provided on pharmacokinetics and possible drug-drug interactions (inhibition or induction) that may alter the metabolism of the drug. Eisai has submitted such data along with the proposed new label.
“Eisai is pleased to submit this new application, which may lead to an additional treatment option for those suffering from partial onset seizures,” said Lynn Kramer, M.D., Chief Clinical Officer and Chief Medical Officer, Neurology Business Group, Eisai. “As a company, we are committed to advancing treatments that will make a difference to those who are affected by epilepsy, and we’re looking forward to the potential for FYCOMPA as a single agent to help more patients suffering from these types of seizures.”
This release discusses a non-approved use for FYCOMPA. It is not intended to convey conclusions about efficacy or safety for such use. There is no guarantee that the proposed use discussed in this release will gain FDA approval.
About Epilepsy
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 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. Generalized seizures account for approximately 40 percent of all epilepsy, with primary generalized tonic-clonic seizures being one of the most common and severe forms of generalized seizures.
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.
SOURCE: Eisai
Post Views: 184
