Aducanumab
In 2007, the company reached a licensing agreement with Neurimmune, a spin-off from the University of Zurich, for the Alzheimer's disease drug, Aducanumab, developed by this Swiss company. Later, Neurimmune sold its rights for license fees for $200 million to Biogen.[6]
In December 2014, Biogen announced that Aducanumab for Alzheimer's treatment was preparing to go through a late-stage trial of its experimental Alzheimer's disease treatment after the medication dramatically improved cognition and reduced brain plaque levels in early-stage study.[54]
In March 2015, Aducanumab became the first experimental Alzheimer's treatment to show significant results in regard to slowing down cognitive decline and reducing brain-destroying plaques.[55] In July 2015, Biogen initiated two late-stage studies called ENGAGE and EMERGE, which will assess Aducanumab in adults with early Alzheimer's disease.[56]
In 2016, Aducanumab decreased amoyloid-beta in the brains of people with early-stage Alzheimer's disease, according to a report published in Nature on August 31, 2016.[57] On March 21, 2019, Biogen announced that the Phase 3 clinical trials of Aducanumab were halted.[58] Biogen announced it would acquire Nightstar Therapeutics for $25.50 per share ($800 million in total). Nightstar focused on adeno-associated virus based gene-therapies for inherited retinal disorders.[59][60] With a setback in their drug research, Biogen's shares fell sharply that same month.[61] It ended the trial of Aducanumab, which it was making along with Eisai.[62] In October 2019, however, they announced that they would pursue FDA approval together with Eisai.[63]
On October 22, 2019, despite two Phase 3 clinical trials being previously halted for futility, Biogen announced its plan to submit for FDA's approval of Aducanumab.[64] In May 2020, Biogen wrapped up construction on a state-of-the-art facility in Solothurn, Switzerland, which will produce Aducanumab by late 2021, alongside its North Carolina manufacturing facility. The monoclonal antibody, co-developed with Eisai, attracted considerable interest from biotech investors when Warren Buffett's Berkshire Hathaway bought 648,447 Biogen shares at a combined value of $192.4 million.[65]
On July 8, 2020, Biogen and Eisai announced that both companies had together successfully submitted for Aducanumab's FDA regulatory and marketing approval.[66]
On June 7, 2021, the FDA gave accelerated approval to Aducanumab under the name Aduhelm,[67] which proved to be controversial.[68][69] The drug was priced at $56,000 US dollars per year, but it was not covered by many insurers as they awaited further proof that the drug was effective.[70] The US Government did not subsidise it outside clinical trials.[71] According to the FDA's website, the drug was proven to reduce amyloid-beta plaques in the brain, which was likely to benefit patients. The FDA has stated that if the post-approval trial did not indicate that Aduhelm works, the drug may be taken out of the market.[72]
Biogen abandoned the drug in January 2024, for financial reasons.[73]
