The US Food and Drug Administration has approved the monoclonal antibody, Soliris (eculizumab), for a rare paediatric blood disorder called atypical hemolytic uremic syndrome while the EMA has recommended approval of the same indication.
The European Medicines Agency is recommending approval of a new macrocyclic antibiotic for Clostridium difficile, Dificlir (fidaxomicin). Developed by Optimer Pharmaceuticals Inc, the antibiotic was approved by the FDA in May 2011.
The European Medicines Agency has recommended restrictions on the use of Multaq (dronedarone), an anti-arrhythmic medicine marketed by Sanofi SA, due to an increased risk of liver, lung and cardiovascular adverse events.
The European Medicines Agency has started a review of orlistat-containing medicines, which are used to treat obesity, to determine whether very rare cases of liver injury affect the medicines’ overall benefit-risk profile.
A supplemental new drug application for the AIDS medicine, maraviroc (Celsentri/Selzentry), has been withdrawn by its developers pending further studies of the drug’s efficacy as a once-daily treatment.
The US Food and Drug Administration has approved two new indications for the osteoporosis drug, Prolia (denosumab), enabling it to be used for cancer treatment-induced bone loss, according to Amgen Inc, the developer.
The US Food and Drug Administration has reorganised the office that deals with oncology drug products in order to take a more disease-specific approach to the evaluation of these medicines. Richard Pazdur will continue as director.
The Roche group has announced European approval of its cancer drug, Tarceva (erlotinib), as a first-line therapy for patients with non-small cell lung cancer whose tumours express mutations of the epidermal growth factor receptor (EGFR).
The US Food and Drug Administration has issued a ‘complete response letter’ to Novartis for its proposed treatment for gouty arthritis, canakinumab, requesting additional data on the drug’s benefit-risk profile in difficult-to-treat patients.
The US Food and Drug Administration has approved a new personalised medicine, Xalkori (crizotinib) together with a diagnostic, for the treatment of patients with late-stage non-small cell lung cancer who have abnormalities of the ALK gene.