Three new medicines and six licence extensions have all been recommended for European approval from the CHMP.
The CHMP, the drug safety and efficacy arm of the EMA, has recommended approval for Otsuka’s Jinarc (tolvaptan) for the treatment of patients with autosomal dominant polycystic kidney disease (ADPKD), and Sanofi’s new insulin Toujeo, the follow up to its blockbuster insulin Lantus.
The CHMP has also recommended granting a conditional marketing authorisation for Novartis’ Zykadia (ceritinib).
Specifically, the licence for the drug is for non-small cell lung cancer patients expressing the anaplastic lymphoma kinase (ALK) mutation.
It is designed to treat patients at an advanced stage and in a second-line setting, after patients have already been treated with Pfizer’s established ALK lung cancer treatment Xalkori (crizotinib).
The CHMP also made six recommendations on extensions of therapeutic indication.
This includes Adenuric, blockbuster oncology treatment Avastin (bevacizumab) from Roche; AbbVie’s auto-inflammatory drug Humira (adalimumab), Menarini’s gout drug Adenuric, (febuxostat), the rare disease drug for kidney disease Soliris (eculizumab), BMS’s HIV pill Sustiva (efavirenz), and finally Amgen’s cancer medicine Vectibix (panitumumab).