Five new drugs put forward for approval in Europe

Five new medicines have been recommended for approval in Europe by the Committee for Medicinal Products for Human Use, including an Orphan drug for thyroid cancer.

Eisai’s tyrosine kinase inhibitor Lenvima (lenvatinib) was backed for the treatment of adults with progressive, locally advanced or metastatic differentiated thyroid carcinoma, whose disease has progressed despite receiving radioactive iodine.

The drug was reviewed under Europe’s accelerated assessment program, and also picked up Orphan designation in 2013. Clinical data show patients treated with Lenvima lived on average 14.7 months longer without their disease progressing than those given a placebo.

While the CHMP concluded that the drug has a safety profile consistent with other similar therapies with “predictable and manageable” side effects, it has requested a further study to investigate the most appropriate starting dose to optimise the benefits and reduce risks.

The Committee also put forward Sanofi Pasteur MSD’s human papillomavirus vaccine Gardasil 9, for the prevention of certain diseases caused by nine types of HPV (6, 11, 16, 18, 31, 33, 45, 52, 58), covering five more strains than its predecessor Gardasil.

Positive options were also handed down for: Helsinn’s Akynzeo (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting; Boehringer Ingelheim’s Synjardy (empagliflozin/metformin) for the treatment of type II diabetes; and Hospira’s generic Voriconazole Hospira(voriconazole) for the treatment of fungal infections.

The Committee also recommended extending the use of Roche’s Tamiflu (oseltamivir) to include the treatment of influenza in infants below one year of age.

By Selina McKee

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