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Compare the efficacy profiles of pimavanserin & aducanumabYes, I know they are different drugs belonging to entirely different pharmacological classes. But even a cursory comparison of the two molecules is instructive as the wisdom of FDA decision-making is still fresh in our mind. Efficacy --Pimavanserin has been shown to be effective in two phase 3 trials, five phase 2 trials, and in non-controlled studies investigating various patient populations. KOL reception of the molecule has been unanimously positive over a 15-year period. The drug has received 2 breakthrough-therapy designations. --Aducanumab was halted in 2 large phase 3 studies after a finding of "futility" by investigators, but upon further review of the data, Biogen claims that 22% of study participants showed less cognitive decline on a higher dose of the drug. However, both the drug and Biogen have come under criticism from experts and analysts. “I surely don’t think that it should be given market approval on the basis of these data,” says Robert Howard, a psychiatrist at University College London who has run clinical trials of potential Alzheimer’s treatments. More positive results from a subset of patients that weren’t preselected at the trial’s launch are not convincing, he says. “[Biogen has] broken all the rules, really, about how you analyze data and report it.” Drug Class --Pimavanserin is the first FDA-approved selective serotonin inverse agonist & the first atypical antipsychotic to show a differentiated, side-effect-free MOA. --Aducanumab belongs to the grab bag known as "beta amyloid targeters." These molecules -- tested by Amgen, Eli Lilly, Merck, Novartis, Roche, and others -- have failed spectacularly over the years, to the point where the beta-amyloid hypothesis has been all but discredited. Controversy -- Adverse publicity against pimavanserin was shown to be baseless and reckless by the FDA in a thorough 2nd review in the summer of 2018. -- "Among 30 Alzheimer’s doctors who are 'very familiar' with aducanumab's data -- 20 academic doctors and 10 community docs -- most said the drug should not be approved." These experts are also "split on whether the phase 3 data that will support Biogen’s FDA application are 'clinically meaningful.'" Commercial -- To date, pimavanserin has netted Acadia over $900 million in an indication that may even be considered orphan-sized. The encomiums from patients, caregivers, researchers, and doctors have been well documented over the years. -- Aducanumab has not been FDA-approved yet. Biogen has even been criticized for spending money to advance the molecule to registration. CONCLUSION Aducanumab is an earth-shatteringly important drug that deserves its priority-review designation. Pimavanserin is only standard-review material. |
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