FDA Okays Lilly's Alzheimer's Disease Diagnostic Agent Tauvid

·2 min read

Eli Lilly and Company LLY announced that the FDA has approved Tauvid (flortaucipir F 18 injection), a radioactive diagnostic agent to image tau neurofibrillary tangles (NFTs) in the brain, for helping evaluate patients suspected of being affected by Alzheimer's disease (AD).

Following this nod, the product became the first and the only approved diagnostic agent to image tau NFTs in the brain.

Per the company, the availability of Tauvid will be limited initially and expand in response to commercial demand and payor reimbursement.

Lilly’s wholly owned subsidiary Avid Radiopharmaceuticals developed Tauvid and Amyvid (florbetapir F 18 injection), which demonstrate the presence of one of the two pathologies, beta-amyloid neuritic plaques and tau NFTs, to enable doctors to evaluate AD patients with cognitive impairment. Until now, anatomic distribution and density of tau NFTs in the brain can be determined only at the time of an autopsy of a dead person.

Notably, Tauvid was evaluated in two clinical studies. Both study 1 and study 2 met the respective pre-specified success criteria.

Shares of Lilly have rallied 14.7% so far this year against the industry’s decrease 1.7%.


We note that Alzheimer's is a fatal condition that causes progressive decline in memory. So, it has always been a highly challenging area and not much progress has been made despite significant investments (both funds and resources). There is no medicine available to slow down the progression of this deadly disease. Several companies including Lilly, Biogen BIIB, Merck MRK and Roche RHHBY failed to develop safe and effective treatment options for this deadly brain disease.

Despite the setbacks, companies continue to invest heavily in developing AD treatments, given the high commercial potential in its market. Therefore, availability of an effective diagnostic agent as Tauvid, which can demonstrate NFTs in the brain may aid doctors to accurately diagnose patients and more comprehensively evaluate them.

Zacks Rank

Lilly currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Biogen Inc. (BIIB) : Free Stock Analysis Report
 
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