Aduhelm continues to live under a cloud. We wrote earlier that the Centers for Medicare and Medicaid (CMM) had decided they will only cover Aduhelm treatments in the context of participation in a controlled drug trial. In other words, to get coverage, you must be accepted into an approved trial. This would be what the FDA calls a phase 4 trial. It's to check "real life" performance of an approved treatment. If it fails the trial, the FDA's original approval may be withdrawn. Of course, CMM and the FDA are requiring the phase 4 trial because there was so much ambiguity in the results of the phase 3 trial. That ambiguity has led many to believe the FDA should never have approved the treatment in the first place.
How long will the trial take? The data-gathering phase itself is four years. It could be five years before results are published and accepted.
So if someone wants to try Aduhelm, are there any phase 4 trials available? They're starting. Biogen has developed a protocol and will begin recruiting participants in 10 centers across the US this month for a trial code named Envision.
In other news, Biogen has just applied to the Japanese regulatory agency for approval of Aduhelm in Japan. Hopefully, things will go better in Japan than they have been going in Europe. As we wrote previously, the European Committee for Medicinal Products for Human Use recommended against approval of Aduhelm for use in Europe. Biogen went back to beef up their application, but they recently gave up. They will need better data, data which might come from the phase 4 trial in the US.
If we hear anything else, we'll let you know.
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