Lilly Gains New Indication For Forteo, But Also A REMS And Patient Registry
Lilly is setting up a voluntary Forteo patient registry to collect data on potential bone cancer risk as part of FDA's approval of a new indication for the osteoporosis treatment. The company is also instituting a Risk Evaluation and Mitigation Strategy to control for the risk
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New bone-targeted agents for osteoporosis must clear significant obstacles to succeed in a highly generic market, but safety concerns with established agents like bisphosphonates and calcitonin offer a foothold. Phase III anabolic candidates from Amgen and Radius Health aim to build new bone, the holy grail of osteoporosis treatment, but R&D in new anti-resorptive mechanisms to halt bone breakdown also continues.
The FDA Amendments Act of 2007 gave the agency many new safety powers and the potential for promotional restrictions and post-marketing fines have understandably received much industry attention. But FDA also appears to be drawing upon its beefed-up authority to increase use of a much older, low-tech safety effort: the patient registry