CHMP backs new cancer, diabetes drugs

A combination diabetes drug from Boehringer Ingelheim/Lilly and a treatment for a rare form of thyroid cancer from Eisai head the list of new drugs backed for approval in Europe by the CHMP.

Eisai’s oral kinase inhibitor Lenvima (lenvatinib) was given a positive opinion from the CHMP as a treatment for adults with progressive, locally advanced or metastatic differentiated thyroid carcinoma (DTC), whose disease has progressed despite receiving radioactive iodine, an indication for which it has orphan status in the EU.

Lenvima was reviewed under the EU’s accelerated assessment procedure and has been given the nod just weeks after being approved for DTC by the US FDA. It is the second kinase inhibitor to be approved in the EU for DTC after Bayer’s Nexavar (sorafenib), and has been predicted to reach up to $1 billion in peak annual sales.

The CHMP has suggested approval should depend upon Eisai agreeing to carry out a further clinical trial to investigate the most appropriate starting dose of Lenvima in order to maintain efficacy and minimise side effects.

Boehringer and Lilly are close to bringing another fixed-dose combination of an SGLT2 inhibitor and metformin to market in Europe after the CHMP gave its blessing to Synjardy, which is based on the two companies’ empagliflozin, sold as Jardiance. The new combination will compete with AstraZeneca’s Xigduo (dapagliflozin/metformin) and Johnson & Johnson’s Vokanamet (canagliflozin/metformin) in Europe.

It is the second single-pill combination therapy Boehringer and Lilly will offer in Europe through their diabetes alliance after Glyxambi – a combination of empagliflozin with DPP-4 inhibitor linagliptin – that was approved in the US in February.

The CHMP also issued a positive opinion for Sanofi Pasteur MSD’s human papillomavirus vaccine (HPV) Gardasil 9, for the prevention of certain diseases caused by nine strains of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58), five more than the earlier version of the vaccine and seven more than rival Cervarix from GlaxoSmithKline. The new shot was approved in the US in December.

Gardasil 9 is recommended for use in boys and girls from nine years of age to protect against cervical cancer, various pre-malignant lesions and genital warts.

Rounding out the latest clutch of approval recommendations, Swiss company Helsinn got the green light from the CHMP for Akynzeo (netupitant/palonosetron) for the prevention of chemotherapy-induced nausea and vomiting and Hospira’s generic antifungal voriconazole was also given the nod.

Akynzeo is the first fixed-dose combination of an NK1 receptor antagonist (netupitant) and serotonin 5-HT3 receptor antagonist to reach the registration stage in Europe and provides long-acting control of symptoms. It was first approved in the US last October.

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