By Dhirendra Tripathi
Investing.com – Eli Lilly (NYSE:LLY) jumped by almost 9% during Thursday’s session as its candidate to treat Alzheimer’s secured breakthrough designation from the Food and Drug Administration.
The breakthrough tag allows the company to expedite the development of the monoclonal antibody.
Such a designation comes when a company is able to demonstrate that its proposed treatment will bring substantial improvement over already available therapies.
Lilly intends to submit a biologics license application for donanemab under the accelerated approval pathway later this year based on data from the TRAILBLAZER-ALZ study.
The safety, tolerability and efficacy of donanemab are also being evaluated in the ongoing randomized, placebo-controlled, double-blind, multi-center Phase 3 study, Eli Lilly said in a note.
Experts and various other stakeholders were waiting for the outcome of Eli Lilly’s study, particularly after Biogen Inc (NASDAQ:BIIB)’s ADUHELM™ (aducanumab-avwa) became the first Alzheimer’s treatment in 18 years to secure fDA’s accelerated approval.
Alzheimer’s is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually, the ability to carry out simple tasks.
There are currently over 50 million people living with dementia around the world, with numbers expected to increase to nearly 152 million by 2050. Almost 10 million new cases of dementia are diagnosed each year worldwide.