Epilepsy treatment FYCOMPA (perampanel) now available on PBS for patients with uncontrolled PGTC seizures in IGE

MELBOURNE, 1 August 2018 – FYCOMPA (perampanel), a once-daily epilepsy treatment from Eisai, is now available on the Pharmaceutical Benefits Scheme (PBS) for uncontrolled seizures. 1

This new PBS listing for FYCOMPA provides reimbursed treatment access to adult and adolescent patients (from 12 years of age) with idiopathic generalised epilepsy (IGE) experiencing primary generalised tonic-clonic (PGTC) seizures.1,3 FYCOMPA is also available via the PBS for patients who experience partial-onset seizures with or without secondary generalised seizures in adults and adolescents from 12 years of age with epilepsy.1,3

Results from a pivotal, Phase III study showed that FYCOMPA is well tolerated and improves the control of PGTC seizures in patients with IGE who are still experiencing seizures despite their current treatment.4Earlier Phase III trials have also demonstrated the efficacy of Fycompa in patients with refractory focal-onset seizures.5 These results indicate that Fycompa can be considered a broad-spectrum AED, with efficacy across both focal-onset seizures and PGTC seizures in IGE.3-5

In the phase III IGE trial, patients treated with FYCOMPA experienced a 50% PGTC seizure responder rate which is significantly higher versus placebo (64.2% vs 39.5%, respectively; P=0.0019).4 FYCOMPA also demonstrated a reduction in PGTC seizure frequency (per 28 days) versus placebo (76.5% vs 38.4%, respectively P<0.0001).4 In addition, 31% of patients were seizure free from PGTC seizures during the 13-week maintenance period when treated with FYCOMPA as an adjunctive therapy, compared to 12% in the placebo group.4

Professor Terence O’Brien, Van Cleef Roet Chair of Medicine (Neurology), Head of Central Clinical School's Department of Neuroscience, Monash University, and Director of Neurology, Alfred Health welcomed the PBS listing as there are currently few treatment options available for patients.

“The number of anti-epileptic treatments for PGTC seizures has always been limited, which has meant a high proportion of patients remain uncontrolled. This can put patients and the people around them at risk, especially when the seizure is sudden and in an unfamiliar environment,” said Prof O’Brien.

Graeme Shears, CEO of the Epilepsy Foundation said “people living with epilepsy would benefit from the PBS listing of Fycompa. Around one third of people living with epilepsy do not gain seizure freedom from existing treatments, and the economic impact of epilepsy means non-PBS listed treatments are not affordable to most people”.

“The availability of Fycompa via the PBS is welcomed news for patients and their treating healthcare professionals. There is now another option for managing this form of seizure that is affordable for patients,” said Carol Ireland CEO Epilepsy Action Australia.

There are up to 250,000 Australians living with epilepsy.6 It is estimated that idiopathic generalised epilepsy makes up 20% of all epilepsies, with PGTC seizures being a common seizure type.7 Such seizures start with a loss of consciousness and a sudden contraction of the muscles, which can cause the person to fall down (tonic phase), followed by rhythmic jerking of the muscles (clonic phase) until the muscles finally relax. There is a serious risk of injury with PGTC seizures, including bone fractures and wounds. 8 Primary generalised tonic-clonic seizures also increase the risk of sudden unexplained death in epilepsy (SUDEP).9

Eisai Australia Managing Director, Jaime McCoy said, “this is the first anti-epileptic drug in over 10 years to be reimbursed in Australia for patients suffering this type of seizure, the PBS listing is important as it is likely to help many patients with idiopathic generalised epilepsy at a time when more Australians are being diagnosed with the condition.”

Safety:

All medicines have adverse effects. The following adverse effects have been commonly reported in patients taking FYCOMPA; dizziness, somnolence, fatigue, irritability, falls, nausea, ataxia, balance disorder, gait disturbance, back pain, vertigo, headache and weight gain.3

Caution should be used in patient groups at risk of these side-effects. Fycompa® may cause behavioural changes which, in some patients, could be serious. As with other AEDs, patients and caregivers should seek immediate advice from a health care professional if any changes in behaviour occur. Fycompa® should not be used in patients with lactose intolerant syndromes, hypersensitivity to perampanel or its ingredients, or pregnant women. Treatment should not be stopped abruptly. Fycompa®, when taken with certain other medicines, may cause side effects or affect how they work.3

Please review the Product Information before prescribing, available from www.eisai.com.au/PI

PBS Information:

Authority required (STREAMLINED). Intractable partial epileptic seizures. Refer to PBS Schedule for full authority information.

Authority required (STREAMLINED). Idiopathic Generalised Epilepsy with Primary Generalised Tonic-Clonic seizures. Refer to PBS Schedule for full authority information.

Fycompa is a registered trademark of Eisai Australia Pty Ltd, PO Box 33004, Melbourne VIC 3004. ABN 73 117 970 993. Eisai Australia Medical Information: 03 9832 9100 or medinfo_australia@eisai.net AU-FYC-18-00007 Date of preparation: July 2018.

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