Eisai goes ahead with its Second Alzheimer’s Drug Amidst Calls for Prior U.S. Approval

Japanese Pharmaceutical Company, Eisai Co., in partnership with Biogen Inc., has announced that it would be pushing ahead with second therapy to combat Alzheimer’s after its historical drug “Aduhelm.” This is because the drug has shown few side effects and might be a more convenient option for patients. 

The Tokyo-originated company has decided to press ahead with the second drug even though the ongoing scrutiny around the FDA’s (U.S. Food and Drug Administration) approval. The hesitancy has caused reservations amongst independent experts who felt that the therapy was not really effective and have gone further to call for a federal probe. 

The company has claimed that its new drug is better as it has no side effects such as bleeding and brain swelling. Moreover, it could easily be made available in an injection accomplishing at-home administration instead of intravenous infusions taken in hospitals. In a statement, the New Jersey-based global president of neurology business of Eisai stated that the second drug referred to as “BAN2401or lecanemab” is similar to Aduhelm in working and reduces amyloid plaques present in the patients suffering from Alzheimer. 

The second drug received a therapy designation from FDA in June with the intention to speed the review of the drug with the capability of treating life-threatening ailments. However, the move does not assure that regulators have gone ahead with the approval. Eisai has decided to meet with FDA regulators before taking on any approach on how to seek approval. 

The nod for Aduhelm had resulted in controversial debates for the get-go. Some scientists are hesitant about whether the drug is actually successful in combating cognitive decline, the most brutal symptom of the disease. Recently, in a worrying decision, Janet Woodcock, the FDA’s acting commissioner, said that she had requested an independent federal review of the approval. 

The analysts have said for now that previous breakthrough designation of the drug was given based on Phase 2 Trials in patients with mild cognitive impairment. Although the data till now is promising, a decision cannot be taken on the compound till the Phase 3 data is made available.  The stakes on approval are high for the company as it has invested 30 years of research on this. Its drug, “Aricept,” known for easing symptoms of Alzheimer but not curing it, had notched the company’s sales to ¥322.8 billion ($2.9 billion) before the expiry of its patent.