On June 8, the FDA issued an accelerated approval to Biogen/Eisai's powdered protein antibody Aduhelm (generic name aducanumab) for the treatment of Alzheimer's disease (AD).
There has been considerable public debate on whether Aduhelm should be approved.
Many experts expressed their support for this. For example, Ronald Petersen, a neurologist at the Mayo Clinic Alzheimer's Disease Research Center, said he's "hopeful" for AD patients. The opposition from the other side is also strong. Some experts voiced their concern about the approval. They argued that there was almost no data to support that Aduhelm can improve the cognitive function of AD patients, illustrating that the clinical benefits of the drug are not ideal.
Despite of controversy in Aduhelm's approval by the FDA, the approval undoubtedly signals a major advance in the field of AD research, which has driven the development of AD treatment research, and presented a promising development prospect for similar drugs and therapies on the market.
In the meantime, it has grabbed a cluster of pharmaceutical companies to return to the potential blue ocean market of AD.
Biogen/Eisai--Lecanemab
Before long after Aduhelm was approved, Biogen/Eisai ushered in another piece of welcoming news. On June 24, Biogen/Eisai declared that the humanized monoclonal antibody Lecanemab (BAN2401) for the treatment of AD has been granted the Breakthrough Therapy Designation (BTD) by the US FDA.
BTD is designed to accelerate the development and review of innovative drugs for the treatment of serious and life-threatening diseases, empowering developers to access closer guidance from the FDA and is hopeful to be eligible for priority review.
Lecanemab is acknowledged as an anti-amyloid β (Aβ) fibril antibody to be targeted to AD patients. This TBD is endorsed based on Phase II study results of early AD of BAN2401-G000-201, a code for the treatment of 856 patients with MCI and mild AD confirmed by the accumulation of amyloid in the brain. It is reported in the results that the level of amyloid was significantly reduced after treatment with the highest dose of Lecanemab.
In March of this year, patient registration of the drug has been performed for a Phase III clinical trial (Clarity) in patients with early AD, and the Phase III trial is running smoothly. The trial included 1,795 registered patients as of March 2021, and it is estimated that indicators of the main evaluation items will be acquired by the end of September 2022. Furthermore, the Phase III clinical trial (AHEAD 3-45) for the effect of Lecanemab in patients with preclinical (latency period) AD whose Aβ accumulation level in the asymptomatic brain has arrived at a critical value or a positive range is also in progress.
Eli Lilly--donanemab
On June 25, Eli Lilly's donanemab ushered in the BTD. Donanemab is noted as an antibody drug under development that targets Aβ protein modified by N3pG (a modified type of β-amyloid protein). The FDA BTD is given based on its Phase II clinical trial TRAILBLAZER-ALZ. This trial aims to evaluate the effectiveness and safety of donanemab in patients with early symptomatic AD. The trial data have been made public at the AD/PD™ 2021 and simultaneously published in the New England Journal of Medicine. The results exhibited that the trial had met the primary clinical endpoint. The BLA is expected to be submitted in H2 of this year.
Bristol-Myers Squibb/Prothena Corporation--PRX005
Therapies other than targeting Aβ have also made headway. On June 25, Bristol-Myers Squibb (BMS) proclaimed that it had procured the exclusive US license for the antibody drug PRX005 developed by Prothena Corporation with 80 million US dollars.
Phase I clinical trials have kicked off. Based on this cooperation, Prothena will garner a total of 230 million US dollars, and be qualified to gain 2.2 billion US dollars, including U...
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