Summary
Regeneron Pharmaceuticals, Inc. (REGN) announced on December 27, 2010, that its anti-nerve growth factor (NGF) program drug, REGN475/SAR164877, which is being developed in partnership with sanofi-aventis, has been placed on clinical hold by the U.S. Food and Drug Administration (FDA). This action follows the FDA's notification of a confirmed case of avascular necrosis of a joint in another company's NGF inhibitor program. The FDA views this as evidence of a class-effect, impacting the development path for REGN475/SAR164877. Importantly, there are currently no ongoing clinical trials for REGN475/SAR164877 that are actively enrolling or treating patients, mitigating immediate impact on existing study participants.
Key Highlights
- 1REGN475/SAR164877, an NGF inhibitor jointly developed with sanofi-aventis, has been placed on FDA clinical hold.
- 2The FDA's decision is based on a confirmed case of avascular necrosis of a joint in a separate anti-NGF program.
- 3The FDA perceives this as a potential 'class-effect' for anti-NGF therapies.
- 4No clinical trials for REGN475/SAR164877 are currently enrolling or treating patients.
- 5This development could significantly impact the future progression of Regeneron's NGF inhibitor program.
Frequently Asked Questions
The FDA placed REGN475/SAR164877 on clinical hold due to a confirmed case of avascular necrosis of a joint observed in another company's anti-nerve growth factor (NGF) program. The FDA believes this indicates a potential 'class-effect' for this class of drugs.
No, the company states that there are currently no ongoing trials with REGN475/SAR164877 that are either enrolling or treating patients. This means the clinical hold does not directly affect any existing study participants.
Avascular necrosis, also known as osteonecrosis, is a condition where bone tissue dies due to a lack of blood supply. This can lead to pain, joint damage, and eventual collapse of the bone.
The clinical hold signifies a significant setback for the development of REGN475/SAR164877, a key drug candidate in Regeneron's pipeline. Investors will likely monitor the company's communication regarding future strategies for this program and its overall R&D pipeline.