Good morning. Elizabeth Cooney here, borrowing the virtual Pharmalittle chair while Ed Silverman takes Manhattan for the hybrid STAT 2022 Breakthrough Science Summit today. In Boston, the skies are cloudy, the feline mascot is sleepy, but the French roast is stimulating. Here are some items to start us off today:
By a narrow margin, an independent panel of advisers to the Food and Drug Administration decided yesterday that data from a single trial of an experimental drug developed by Amylyx Pharmaceuticals were not sufficient to conclude the therapy was an effective treatment against ALS, STAT reports. The vote, which followed heartfelt appeals from ALS patients who testified during the hearing, was 6-4 — closer than many expected given the FDA’s previously stated position that data from a single clinical trial of the Amylyx drug, called AMX0035, showed only a modest benefit and “may not be sufficiently persuasive” to support approval.
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