GSK malaria vaccine heads EMA recommendations

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The latest set of recommendations by European Medicines Agency were dominated by positive opinions for the world’s first malaria vaccine from GlaxoSmithKline and Sanofi/Regeneron’s injectable cholesterol-lowering treatment.

The EMA’s Committee for Medicinal Products for Human Use has given its backing to Mosquirix, after nearly 30 years of development by GSK and the PATH Malaria Vaccine Initiative. It will be approved for the prevention of malaria in young children in sub-Saharan Africa aged six weeks to 17 months.

While the decision has been hailed as historic, enthusiasm has been tempered somewhat by Mosquirix data which shows that it prevents just one in three cases of clinical malaria, and requires three doses of the jab (previously known as RTS,S), plus a booster. Sir Andrew Witty, GSK’s chief executive, admitted that “while RTS,S on its own is not the complete answer to malaria”, its use alongside bed nets and insecticides would provide “a very meaningful contribution” to the fight against malaria.

The other highlight of the CHMP meeting was a thumbs-up for Sanofi and Regeneron’s Praluent (alirocumab), which is designed to lower high levels of cholesterol in people for whom statins are not an option. The drug belongs to a new class of medicines called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors and has also just been approved in the USA.

Europe has already approved Amgen’s rival PCSK9 inhibitor Repatha (evolocumab) earlier this week and analysts expect both of the drugs to become multibillion-dollar blockbusters. Their potential to cut bad cholesterol has proved impressive in clinical trials but cost is likely to be a major issue in terms of access.

Other treatments that got the backing of the CHMP include Astellas and Basilea’s Cresemba (isavuconazonium sulfate) for two rare but life-threatening fungal infections – invasive spergillus species, and mucormycosis. The CHMP also issued a positive opinion on Shire’s Intuniv (guanfacine) to treat attention deficit hyperactivity disorder in children and adolescents aged six to 17 years old for whom stimulants are not suitable.