This past Friday, accelerated approval has been issued by the U.S. Food and Drug Administration (FDA) for a new drug created to try and treat Alzheimer’s.
Known as Leqembi, the new drug was crafted by Japanese pharmaceutical company Eisai and is seeking to work with Biogen in order to bother market and commercialize it. The accelerated approval it was issued is based on a small study that highlighted that a number of patients who were given the medicine “had significant dose- and time-dependent reduction of amyloid beta plaque,” which is known to be an indicator of Alzheimer’s.
When a person has Alzheimer’s disease, the level of the beta-amyloid protein group together in order to create barrier plaques muddying up the connections between neurons and hindering the overall ability of the cells to work.
The price of this drug will come to a fee of $26,500 annually for someone who is of average weight. As of writing, Medicare has declared that it will not be offering coverage for the treatment as of yet.
Experts in the disease stated that the drug does offer a number of modest advantages for those that have minor cognitive impairment or are early-stage Alzheimer’s disease.
The approval of this drug harkens back to Aduhelm, another treatment for the disease that was approved as of June 2021 by the FDA. The drug was made by Biogen, but a large number of scientists researching the disease stepped up to speak out against it. because of a number of unknown upsides and the possibility of brain bleeding and swelling risks, many large health groups have elected to not provide the drug to various patients. This treatment was eventually tossed aside within the marketplace due to restrictions from Medicare concerning its coverage. Eisai had been working alongside Biogen on the drug, but chose to leave the relationship last year.
An investigation from Congress initiated back in December found out that the procedure from the FDA in its approving of Aduhelm was “rife with irregularities.” The work from the agency alongside Biogen was questionable. The overall investigation also discovered that biogen set up a high cost for the drug.
It was explained by Democratic Representative Frank Pallone of New Jersey in a release that the findings “[document] the atypical F.D.A. review process and corporate greed that preceded F.D.A.’s controversial decision to grant accelerated approval to Aduhelm.”
An additional internal inquiry from the FDA, which was carried out prior to the drug being greenlit, highlighted that people within the agency did not listen closely enough to differing opinions from the FDA’s statistical team, which made the argument that there had not been enough proof that the drug actually worked. Additionally, it was discovered that its work alongside Biogen, the maker of the drug, “exceeded the norm in some respects.”
This new drug, Leqembi, still has a number of possible dangers. It was highlighted by the FDA that it is going to be setting up a warning about Leqembi for amyloid-related imaging abnormalities (ARIA), which can lead to life-threatening and serious situations, but typically no symptoms are present.