The European Medicines Agency's drug-review committee got busy today issuing recommendations--and rejections--for a laundry list of new meds and new indications for old ones. Here are the highlights.
- Novartis' bone drug Aclasta got the nod for treating men at increased risk of fracture, including those with a recent low-trauma hip fracture. It's currently approved only for use in post-menopausal women and for treatment of Paget's disease.
- Johnson & Johnson's blood cancer med Velcade got a thumbs-up for a new indication: use in combination with melphalan and prednisone in previously untreated multiple myeloma patients who aren't eligible for high-dose chemo. Velcade is already approved as monotherapy for patients who've tried at least one other treatment.
- Bayer's anticlotting medicine Xarelto--one of its leading drug hopefuls--got the committee's blessing for preventing clots after surgery.
- Sanofi-Aventis' attempt to broaden use of its cancer meds Taxotere and Docetaxel Winthrop failed to get CHMP's OK; both meds are already approved for breast cancer treatment in combination with other anticancer meds.
As you know, a committee decision isn't guaranteed to be ratified by the EMEA itself, but it generally is.
- see the roundup from CNN Money