Malaria vaccine and Sanofi’s Praluent lead CHMP opinions

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

First up, 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, acknowledged 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 World Health Organisation will discuss Mosquirix at a meeting in October. If recommended, individual governments in malaria-affected regions will then decide whether to adopt the vaccine. It will cost £8.50, if there is enough demand for it to be mass-produced and any profit will be reinvested into tropical medicine research by GSK.

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.

Europe 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.

A good day got better for Sanofi and Regeneron as hours later, the US Food and Drug Administration approved Praluent, making it the first PCSK9 inhibitor to reach the market across the Atlantic. The list price of the drug is about $14,600 a year, well up on the $10,000-$12,000 that had been forecast.

Other treatments that got the backing of the CHMP include Basilea’s Cresemba (isavuconazole) for two rare but life-threatening fungal infections – invasive aspergillosis 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.

Rounding up the review, the agency recommended granting marketing authorisation for Keryx Biopharma’s Fexeric (ferric citrate) for hyperphosphataemia, Baxalta’s Obizur (susoctocog alfa) for acquired haemophilia, Grünenthal’s Zalviso (sufentanil) for post-operative pain and Merck Sharp & Dohme’s Zerbaxa(ceftolozane/tazobactam) for abdominal and urinary tract infections, plus acute pyelonephritis. The CHMP also backed Eli Lilly’s generic of its own drug Alimta (pemetrexed) and Sandoz’ version of the treatment for malignant pleural mesothelioma and non-small cell lung cancer.

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