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BREAKING NEWS: FDA Panel Votes Against New ALS Drug - medtigo

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BREAKING NEWS: FDA Panel Votes Against New ALS Drug

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The US Food and Medication Administration’s advisory council opted not to recommend approval of an experimental drug for amyotrophic lateral sclerosis in a tight decision (ALS).

Patient advocacy groups lobbied hard for fast-track approval, and the panel’s decision was carefully followed. However, the committee found 6-4 on Wednesday that evidence from single mid-stage research sponsored by Amylyx Pharmaceuticals was insufficient to show that the company’s medicine makes a significant improvement in patients’ lives.

According to the Associated Press and Health Day, Kenneth Fischbeck, MD, of the US National Institutes of Health, remarked during the panel meeting, “I believe it would be a disservice to the patients and their families to approve a medication of unclear benefit.” “If it turns out not to be effective, it obstructs the development of truly effective medicines.”

Fischbeck and his panelists expressed hope that the results of more extensive research, which is now underway, will provide further evidence on the medicine known as AMX0035 for the time being. Even those who voted in favor of the treatment admitted that the decision was difficult. “I went back and forth throughout the day, but in the end, I agreed with the [drugmaker’s] principal analysis,” NIH biostatistician Dean Follman told the Associated Press.

Notably, the vote is non-binding, and the FDA has until the end of June to decide whether to approve the medicine. The panel’s decision might confirm the agency’s negative review, published just days before the meeting. The Amylyx study was criticized for its limited size, missing data, and sloppy statistical analysis.

The FDA has emphasized the importance of “regulatory flexibility” while evaluating medications for terminal diseases such as ALS. Given the scarcity of ALS therapy choices, the fact that the panel vote was close could sway the agency toward approval.

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