With advancements in medical technology, new solutions for treating diseases we previously had no answer for are emerging. One of the latest examples, Lecanemab, marketed as Leqembi, shows that the FDA’s Accelerated Approval Program is working. After displaying a potential to slow the progression of Alzheimer’s Disease, Leqembi met FDA’s preliminary requirements for addressing an unmet need in the market, granting them expedited approval. While the drug has gone through Phase III clinical trials, its safety and effectiveness will continue to be monitored in more extensive ongoing post-approval trials known as Phase IV studies. If these subsequent trials confirm the drug’s therapeutic value, Leqembi could be granted full traditional approval.
It is expected that more investigational drugs will be accepted for the accelerated approval program, especially where there is an absence of approved drugs in the market for conditions shown to be life-threatening or fatal without them. FDA has granted such status to cancer drugs, a great example of the program working to address critical needs. Approvals such as these continue to display the clinical value of expedited conditional approvals and Phase IV monitoring of the drug’s safety after they enter the market to the benefit of patients in dire need. Programs like accelerated approval and Phase IV monitoring offer faster access to innovative new drugs while allowing for the generation and consideration of additional valuable data.