The medical journal Lancet has called for immediate changes in the approval processes and regulation of human trials of biological drugs.
The medical journal Lancet has called for immediate changes in the approval processes and regulation of human trials of biological drugs. This call came after the trial of TGN1412 ended in disaster with six patients admitted in the hospital in serious condition.
The journal says that since the UK Medicines and Healthcare Products Regulatory Agency (MHRA) authorized the trial, it is the agency’s responsibility to review the protocol. However there was no fault with the quality of the test drug, no contamination, no dosing error, yet the trial went wrong. "The TGN1412 events indicate urgent change is needed in the... regulation of phase I trials of biological agents," the journal said. The report stresses that regulatory agencies must take into account predicting toxicity of activating antibodies compared with conventional small molecule drugs.
