UCB's non-cannabis drug for severe epilepsy gets NHS okay

People with a form of severe epilepsy will now be able to get NHS access to a new drug from UCB, Fintepla, that could significantly reduce their seizures.

The NHS will fund Fintepla (fenfluramine) starting today after cost-effectiveness watchdog NICE recommended it as an option for controlling seizures associated with Lennox-Gastaut syndrome (LGS) in people aged 2 years and over.

The drug is the first non-cannabinoid option for patients with LGS and an alternative to Jazz Pharma's Epidyolex (cannabidiol) and clobazam, which has been available on the NHS since early 2020, but has to be administered through designated regional paediatric centres.

LGS is a severely debilitating form of epilepsy that generally begins in early childhood and leads to frequent seizures of different types – including 'drop' seizures, in which patients suddenly lose muscle control and fall, risking serious injury – and also causes severe learning and behavioural disorders. It is highly resistant to many anti-epileptic drugs.

NICE estimates that there are around 1,400 people who will now be eligible for treatment with Fintepla, which was previously backed by NICE for Dravet syndrome, another severe epilepsy disorder that can also be treated with Epidyolex.

Professor Stephen Powis, national medical director for NHS England, said that Fintepla offers children with LGS and their families "the chance for greater stability and a better quality of life," as it can be taken at home to help control and reduce seizures.

He added that it will offer "a vital alternative for those who can't tolerate existing cannabis-based treatment."

Michael and Paul Atwal-Brice have two older boys with severe epilepsy, including one – Levi – who suffers from LGS. They described the decision on Fintepla as "really positive news for families like ours. Levi suffers from extremely serious seizures, and having to use a cocktail of drugs to treat them has been really difficult. The side effects have been impossible to manage, as it's hard to know which medication is causing them. Fenfluramine is potentially life-changing for Levi and our family."

Fintepla was acquired by UCB when it completed its $1.9 billion takeover of Zogenix in March 2022, saying at the time that it reckoned Fintepla had blockbuster sales potential and would be a successor to its other epilepsy therapies - including Keppra (levetiracetam), a former blockbuster, but which is now facing generic competition. Sales of the drug were €154 million ($161 million) in the first half of 2024, up more than 50%.

NICE said that the decision to add LGGS to its recommendations for Fintepla follows an appeal by the company, as well as an offer of an improved discount to its price.

The drug is recommended if the frequency of drop seizures is checked every six months and the drug should be stopped if the frequency is not reduced by at least 30% compared with the six months before starting treatment.

Fenfluramine is an old drug and achieved some degree of notoriety in the 1990s as half of the fen-phen weight-loss therapy, which was banned after the combination was linked to cardiovascular disease including heart valve problems. Fintepla includes fenfluramine at a much lower dose, however, and there hasn't been any evidence of cardiovascular problems in its clinical trials.