Rises in long-term Alzheimer’s Disease (AD) incidence threaten to eliminate the SSRI (selective serotonin reuptake inhibitor) antidepressant from the European market in four years, as the E.U. investigates the risks and benefits of new treatments in light of the current high rate of neurodegenerative disease.
So says the latest results of a commercial version of the drug, aducanumab, reported earlier this year in the Journal of Alzheimer’s Disease. The U.S. Food and Drug Administration (FDA) approved aducanumab as a treatment for mild to moderate symptoms of AD in December 2018.
The E.U. press release that presented the preliminary results stressed the fact that “no behavioral or cognitive differences were found,” even in patients who had been treated for an additional 2 years with aducanumab compared to placebo. Further, the E.U. press release says that “the study was not designed to confirm [aducanumab] as the best, least-risky or most effective treatment.” That suggestion is somewhat interesting, since the endpoints in the trial are known.
The clinical study was designed to include, among others, 619 patients at an average age of 62 with “moderate to severe” symptoms of AD. Those treated with aducanumab were compared to another group of patients that was treated with a placebo. After 18 months, subjects treated with aducanumab showed an increase in the incidence of AD compared to placebo, although neither patients treated with aducanumab nor the placebo group experienced significant improvements.
Authors of the recently published report presented here are frustrated with the negative press surrounding the current AD treatment.
In a press release on its website, Biogen that Biogen Development, Inc. paid their drug’s manufacturer, Ionis Pharmaceuticals, Inc., $5.25 million in 2013, more than two years after the contract expires. Biogen pointed out that the drug “was successful in a Phase 3 study” and that Biogen also “made the initial payment under the [2013] contract” as it saw the possible progress of AD treatments. However, early research efforts for AD treatments led by the pharma have since gained significant research support from outside laboratories.
The first step toward establishing a treatment for Alzheimer’s disease is human trials of drugs that can produce side effects, increase insulin resistance, increase the risk of cancer, damage renal tissues, or address other inflammatory cytokines found in the blood of people with AD. Thus far, clinical trials have not been successful. However, the use of ezetimibe has been the subject of an investigation by the E.U. Genitourinary and Hematological Drugs Medicines Surveillance Centre. Among the benefits found in ezetimibe was that it prevented inflammation. There is an “exorbitant cost” of treatments with such side effects, especially when we consider that “current treatment options are nothing more than assisted suicide with extraordinary expense.”
Would an approval of aducanumab in Europe mean more money for pharma or less money for the E.U.? There’s no guarantee of the latter, but it doesn’t look good for the former.
(Ralph Abraham, Ph.D., is the Academic Executive Director at the Cardiovascular Research Foundation based in Texas and lecturer at the Duke University School of Medicine in Durham, North Carolina.)