Novartis’ meningitis vaccine Bexsero has been recommended for approval in Europe in people aged over two months.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Bexsero (meningococcal group B vaccine), putting it on track to become the first product of its type to protect all age groups, including infants, in the EU.
Novartis will now enter negotiations to try to get Bexsero included on national immunisation programmes, and expects the product to start rolling out across Europe in 2014, according to Andrin Oswald, head of Novartis’ vaccines and diagnostics division.
Currently available meningococcal B (MenB) vaccines do not offer broad protection against the strain, which accounts for up to 90 per cent of all meningococcal disease cases in some European countries, says Novartis.
MenB “is easily misdiagnosed, can kill within 24 hours and may cause serious, life-long disabilities”, according to Novartis, and this has prompted some analysts to predict blockbuster sales of $1bn-plus for the product, which tackles three MenB strains.
Bacterial meningitis fatality rates are 5 to 10 per cent in industrialised nations and up to 20 per cent in developing countries, according to the World Health Organization (WHO).
“This is the most significant step forward in the fight against meningitis in recent years,” said the Meningitis Trust in a statement, noting that there has been an annual average of 1,870 cases of MenB in the UK. Ten per cent of those affected by the condition die, and a third of survivors will be left with long-term after-effects, it added.
In the US, Novartis is in the midst of discussions with the FDA on appropriate surrogate markers for efficacy, which Oswald said was a “difficult, complex and scientific negotiation”. Thereafter the company will start a phase III trials programme.
Bexsero is seen as a critical new product to help boost the fortunes of Novartis’ vaccines division, which has been making losses in recent quarters. As well as Bexsero, Novartis already markets the meningitis vaccine Menveo, which is used to protect against meningitis groups A, C, W135 and Y. It was approved in Europe in March, 2010.
Thalassaemia candidate
Meanwhile, the CHMP also gave its backing to Novartis’ Exjade (deferasirox) as a treatment for non-transfusion-dependent thalassaemia (NTDT) syndromes, a group of genetic disorders characterised by red blood cell problems and anaemia.
Clinical trials have shown Exjade significantly decreases iron burden in NTDT patients compared to placebo, with similar overall adverse event rate, and if approved it will become the first oral treatment available for the disorders in Europe.
Exjade is already approved in more than 100 countries to treat iron overload due to frequent blood transfusions, bringing in $633m in sales in the first nine months of 2012.