Patients with epilepsy now have access to a new, first-in-class treatment option following the roll-out of Japanese drugmaker Eisai's Fycopma in the UK.
Fycompa (perampanel) is the first in an entirely new class of therapies for uncontrolled partial epilepsy, the most common form of the condition.
The drug is the only licensed anti-epileptic drug (AED) to selectively target AMPA receptors, which play a crucial role in the spread of epileptic seizures.
As the firm notes, this gives Fycompa a different mechanism of action to rival AEDs on the market, and the drug also carries the advantage of having a once-daily dosing regimen.
Around 600,000 people in the UK suffer from epilepsy, but despite current care there are around 1,000 epilepsy-related deaths in the country, highlighting the need for new treatments.
Most of these deaths are linked with epileptic seizures, and it is estimated that about 400 every year could be avoided.
And while up to 70% of patients could be seizure-free through proper diagnosis and optimal treatment, this is only achieved in about half of all patients, again underscoring the huge room for improvement in outcomes.
A Phase III clinical trial of Fycompa showed that 8mg and 12mg doses of the drug produced statistically-significant reductions in frequency of seizures compared to placebo in patients experiencing partial-onset seizures despite treatment with one to three other AEDs.
Response rates in the study - defined as 50% or greater reduction in seizure frequency - were 14.7% for placebo, 33.3% for Fycompa 8mg and 33.9% for 12mg, clearly showing its potential benefit to patients.
Eisai has chosen to launch Fycompa in the UK at a flat rate NHS list price of £5.00, per patient, per day, irrespective of the dose of the medicine, and the price compares well with other recently launched branded AEDs, Gary Hendler, Eisai EMEA& Russia, President and Chief Executive, told PharmaTimes UK News.
"In these times of healthcare austerity, and with increasing uncertainty about the future of medicines reimbursement, our pricing reflects our commitment to making perampanel available for patients at an affordable price, improving our partnerships with all relevant stakeholders within the NHS to ensure that patients who suffer from difficult-to treat, uncontrolled epilepsy have rapid and sustained access to the medicine," he said.
Hendler also noted that "as companies such as Eisai research, develop and launch new medicines in the UK, there is an increasing need for the NHS to embrace these new therapies, encouraging better patient outcomes, greater levels of inward investment and improvements in domestic innovation".
Fycompa won approval in Europe in July this year, but across the pond things haven't run quite as smoothly.
In July last year US regulators turned down Eisai's application to market Fycompa there, requesting a reanalysis of data. However, a resubmission of the marketing application was accepted in March, and the drugmaker is expecting a decision next month.
The global supply of Fycompa will be manufactured, packaged and distributed from Eisa’s new £100-million facility in Hatfield, Hertfordshire, the firm said.