U.S. Medicare says no change to Alzheimer's drug restrictions | Reuters

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I don’t doubt this compound shows more clinical benefit than Aduhell (almost anything probably would), but that’s likely just due to enhanced cerebral blood flow, which results when the plaques are removed and brain blood vessels become less constricted. While there’s nothing wrong with that per se, removal of the plaques undermines the structural integrity arteries and makes them significantly more vulnerable to hemorrhage. Four people died in the clinical trial from brain bleeds. That number will go up exponentially as the therapy achieves uptake.
 






anonymous said:
I don’t doubt this compound shows more clinical benefit than Aduhell (almost anything probably would), but that’s likely just due to enhanced cerebral blood flow, which results when the plaques are removed and brain blood vessels become less constricted. While there’s nothing wrong with that per se, removal of the plaques undermines the structural integrity arteries and makes them significantly more vulnerable to hemorrhage. Four people died in the clinical trial from brain bleeds. That number will go up exponentially as the therapy achieves uptake.
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But will it make Lieogen money?
 












Ominous signs that do not bode well for Biogen/Eisai: FDA plans an Advisory Committee to discuss the lecanemab application, and Billy Dunn the biggest Biogen cheerleader at the FDA abruptly resigned end of last month.

Typically, for full approval of a drug, FDA requires 2 adequately controlled clinical trials showing efficacy and safety.

Of the 2 lecanemab clinical trials Biogen/Eisai submitted to the FDA (and other regulators), data from one trial was statistically positive (CLARITY) though clinically marginal. The other clinical trial, a Phase IIb study was negative for clinical efficacy.

Safety is also of concern: 3 outcomes of death and possibly more where lecanemab cannot be entirely ruled out, bleeding in the brain, and a high incidence of infusion reactions.
 






anonymous said:
Ominous signs that do not bode well for Biogen/Eisai: FDA plans an Advisory Committee to discuss the lecanemab application, and Billy Dunn the biggest Biogen cheerleader at the FDA abruptly resigned end of last month.

Typically, for full approval of a drug, FDA requires 2 adequately controlled clinical trials showing efficacy and safety.

Of the 2 lecanemab clinical trials Biogen/Eisai submitted to the FDA (and other regulators), data from one trial was statistically positive (CLARITY) though clinically marginal. The other clinical trial, a Phase IIb study was negative for clinical efficacy.

Safety is also of concern: 3 outcomes of death and possibly more where lecanemab cannot be entirely ruled out, bleeding in the brain, and a high incidence of infusion reactions.
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Eisai has never dealt with an advisory committee. It'll be a blood bath.
 






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