A first-of-its-kind osteoporosis drug lowers the risk of bone fractures better than some existing treatments, two studies suggest, and could soon add a more expensive but easier option to the booming market. Amgen Inc. will stress that only two shots of its genetically engineered denosumab, which could be approved for sale this fall, are needed each year. That's important because many patients stop taking other drugs due to side effects or frequent dosing.
Still, he called the drug a "tour de force of modern molecular medicine" because it is potent and was designed specifically to block one pathway involved in the natural breakdown of bone cells. The Food and Drug Administration on Tuesday released its review of denosumab, with staff citing concerns about increased rates of skin infections and some tumors. That report comes just ahead of a meeting Thursday when outside advisers will weigh the drug's safety and effectiveness and recommend whether to approve it.