Global pharmaceutical and healthcare company Eli Lilly and Co. (LLY:NYSE) today announced that "the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, its investigational antibody therapy for Alzheimer's disease (AD)."
Eli Lilly explained that Breakthrough Therapy designation is awarded in order help accelerate the development and review process of promising drugs designed to treat serious medical conditions for which there are no other available alternatives or when clinical evidence suggests that a new medicine displays substantial and significant improvements in achieving primary clinical endpoints compared to drugs and therapies that were previously granted full FDA approval.
The company stated that "the FDA Breakthrough Therapy designation is based on clinical evidence for donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG." The firm advised that the approval was based upon the results compiled from its Phase 2 TRAILBLAZER-ALZ Trial, which was structured to evaluate the efficacy and safety of donanemab in patients with early, symptomatic AD.
Eli Lilly advised that based on data obtained from the TRAILBLAZER-ALZ trial, later this year it intends to prepare and submit a biologics license application (BLA) for donanemab under the FDA's accelerated approval pathway program.
The company stated that the Phase 2 TRAILBLAZER-ALZ trial is a randomized, multi-center study designed to measure donanemab's safety, tolerability and efficacy in patients diagnosed with early symptomatic AD. The study enrolled a total of 272 patient subjects who were studied over a period of 76 weeks for how they progressed according to the Integrated Alzheimer's Disease Rating Scale (iADRS). The firm added that "key secondary endpoints included changes between baseline and 76 weeks in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), ADCS-iADL, MMSE, and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scores."
The company noted that that AD causes progressive decline in memory and cognition and is a fatal illness. The firm pointed out that "dementia due to Alzheimer's disease is the most common form of dementia, accounting for 60-80% of all cases." The disease effects over 50 million people globally and is forecast to triple to 152 million by 2050. The debilitating dementia causing disease takes its toll on both patients and caregivers and comes with an enormous societal and economic cost.
Eli Lilly is a global pharmaceutical and healthcare company headquartered in Indianapolis, Ind. The company has a large portfolio of medicines for use in treatment in the areas of bone muscle joint, cardiovascular, diabetes, endocrinology, immunology, neurodegeneration, neuroscience, oncology and pain. The firm employs approximately 34,000 people worldwide and is actively involved in all phases of drug development, manufacturing, marketing and distribution to around 120 countries. In addition to its human pharmaceutical products, the company is also engaged in the development of sale of animal pet and livestock feed and health products. The company operates in the U.S. and 14 other countries and has a market cap of over $208 billion.
Eli Lilly began the day with a market cap of around $208 billion with approximately 959 million shares outstanding. LLY shares opened more than 8% higher today at $234.92 (+$17.82, +8.21%) over yesterday's $217.10 closing price and reached a new 52-week high price this morning of $239.97. The stock has traded today between $230.42 and $239.37 per share and is currently trading at $234.25 (+$17.15, +7.90%).[NLINSERT]
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