FDA Puts Clinical Hold on Regeneron, Teva Study

Oct 17, 2016

Reuters

The FDA has placed a clinical hold on a mid-stage Regeneron Pharmaceuticals and Teva Pharmaceutical study of an experimental backpain drug.

The agency decision followed a case of a type of joint inflammation in a patient who was given a high dose of the injectable drug, fasinumab.

The treatment is designed to block nerve growth factor -- a protein involved in transmission of pain signals -- and is a potential alternative to opioids.

According to the FDA, a clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. When an ongoing study is placed on clinical hold, no new subjects may be recruited to the study and placed on the investigational drug; patients already in the study should be taken off therapy involving the investigational drug unless specifically permitted by FDA in the interest of patient safety.

Following the FDA decision, Regeneron has completed an unplanned interim review of data and has stopped dosing patients.

Read the Reuter's article

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