Eisai EMEA, an R&D based pharmaceutical company, has established a named patient access program to ensure patients continue to receive an uninterrupted supply of the anti-epilepsy drug Fycompa (perampanel), following the temporary suspension of commercial distribution in Germany. The access program will be managed by Clinigen Global Access Programs (GAP), a U.K.-headquartered specialty global pharmaceutical company.
The access program is not expected to be utilized until the beginning of 2014, as there are sufficient stocks of Fycompa in Germany to meet demand until the end of December. All patients will receive an uninterrupted supply at no cost to the German healthcare system. The access program will remain in place until commercial distribution resumes. The company intends to submit Fycompa for reassessment at the earliest opportunity.
"As approximately 3,000 to 4,000 people with epilepsy in Germany have benefitted from this treatment since its launch in September 2012, our priority is to ensure that these patients continue to receive an uninterrupted supply of the treatment,” said Gary Hendler, president and chief executive officer, Eisai EMEA. “Eisai has partnered with Clinigen GAP so patients can continue to receive Fycompa after the temporary suspension has come into effect and German stock of the drug is exhausted at the end of the year."
Discovered and developed by Eisai in the U.K. and Japan, Fycompa is the first and only approved anti-epileptic drug in Europe with a mode of action that selectively targets AMPA receptors, thought to play a central role in seizure generation and spread. The successful treatment of partial-onset seizures remains a challenge for patients and physicians, as over 30% of patients do not achieve seizure freedom despite appropriate therapy with anti-epileptic drugs.
Fycompa was granted marketing authorization by the E.C. July 2012 and is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.