Sanofi says that regulators in Europe have started to evaluate its four-in-one influenza vaccine.
The French drugmaker’s Sanofi Pasteur unit announced that a decentralised marketing authorisation application has been accepted for review in the European Union for a quadrivalent formulation of its three-strain seasonal influenza vaccine Vaxigrip. France will act as the reference member state.
Currently-licensed vaccines are trivalent and are formulated every year, based on seasonal recommendations made by the World Health Organisation and national authorities. They contain inactivated strains that confer protection against two influenza A virus subtypes and one type B virus.
However, for over a decade, two distinct influenza B families have co-circulated, Sanofi noted, making it difficult to predict which B-lineage strain will predominate in a country or in a region in seasons to come. The new vaccine includes two A and two B strains corresponding to both of the aforementioned B lineages.
Olivier Charmeil, Sanofi Pasteur’s chief executive, said the inclusion of the four flu viruses anticipated to circulate in the forthcoming season “has the potential to reduce the risk of influenza disease and influenza-related complications, specifically hospitalisations and deaths among those, at risk, who contract the disease”.
In October 2012, a supplemental Biologics License Application was filed in the USA for a quadrivalent formulation of Sanofi’s Fluzone vaccine. An action date is anticipated in the second quarter of 2013.
Earlier this month, rival GlaxoSmithKline’s quadrivalent seasonal influenza vaccine, Influsplit Tetra/Fluarix Tetra, was granted marketing authorisation in Germany and the UK, the first four-strain flu jab to be approved in Europe.
Sanofi increases malaria treatment production
Meantime, Sanofi and OneWorld Health, the not-for-profit drug development affiliate of the Program for Appropriate Technology in Health (PATH), have launched a commercial-scale production line for semisynthetic artemisinin, a move they say is “a pivotal milestone in the fight against malaria”.
Global demand for artemisinin is the most effective malaria treatment available but the existing botanical supply – which is derived from the sweet wormwood plant – is inconsistent. Therefore, Sanofi says that having “multiple sources of high-quality artemisinin will strengthen the artemisinin supply chain, contribute to a more stable price and ultimately ensure greater availability of treatment”.
The company notes that the production line at its facility in Garessio, Italy, will be able to produce enough artemisinin, using technology developed by US firm Amyris, for around 80-150 million artemisinin-based combination therapies by 2014.
