Biogen seeks the FDA approval to revive its Alzheimer’s drug Aducanumab

Not a long time ago this year, Biogen announced the halting of Phase III clinical trials, EMERGE and ENAGE, of its most looked upon drug aducanumab under simulations for the treatment of Alzheimer’s disease called futility analysis.

The drug was designed to help patients struggling with mild cognitive impairment and mild dementia due to Alzheimer’s disease. The failure of the trials to produce positive results and failure to meet the primary end-point led the Biogen and Eisai to decide on halting the further analysis of aducanumab.

Shockingly enough, Biogen has revived the hopes of several patients by announcing the resurrection of its long-lost drug. The company is planning to submit marketing approval aducanumab of to the US FDA quoting that initial review was not in the lines of the data studied for more patients.

The decision came after the successful conduct of Phase III EMERGE study which showed positive results in controlling the disease when the subjects took a relatively higher dose of aducanumab supporting the outcomes from the EMERGE.

However, there still lies a hurdle. The FDA demands two successful trials for this drug and the company only has EMERGE to support its case.

Alzheimer is a complex, degenerative disorder of the central nervous system affecting around 5.8 million people of age 65 and older. The onset of the disease starts way before the onset of its symptoms. Due to the non-availability of a standard diagnosis test, the determination of the exact cause of the disease becomes almost impossible.

As per a survey by the U.S. Census Bureau, the Alzheimer’s disease prevalence is going to increase as the American demography is going to shift from the fertile population to the older one, from 55 million in 2019 to 88 million by the year 2050.

Alzheimer’s therapy market is one of the toughest markets to survive in. Where several candidates failed, and many companies gave up, Biogen’s move to bring the drug back in the competition is a brave move. However, the future of aducanumab is still in dark, and the assurance of the success is still uncertain.

There exist companies that are running the trials to dominate the Alzheimer’s disease therapy market, as the field remains untouched. Some of the key players in the therapeutic market of Alzheimer’s Disease (AD) at a global level are Neurotrope bioscience, AgeneBio, Novartis, Cortexyme, Eisai, TauRx Therapeutics, Otsuka Pharmaceutical, Genentech, MGC Pharmaceuticals, Alkahest, AZ Therapies and others. Some have recently eneterd the market while others have spent years in finidng a standard efficient cure to treat Alzheimer’s disease.

Alzheimer’s disease pipeline include Bryostatin-1 (Neurotrope Bioscience), AGB101 (AgeneBio), CAD106 and CNP520 (Novartis), COR388 HCL (Cortexyme) E2609 or Elenbecestat (Eisai), TRx0237 (TauRx Therapeutics), brexpiprazole (Otsuka Pharmaceutical), RO7105705 (Genentech), AKST/GRF6019 (Alkahest), ALZT-OP1 (AZ Therapies) and several others, which are still in different phases of the clinical trials.