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FDA Rejects Accelerated Nod to Lilly's (LLY) Alzheimer's Drug

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Eli Lilly (LLY - Free Report) announced that the FDA issued a complete response letter (“CRL”) to its regulatory filing seeking accelerated approval of a new Alzheimer’s drug, donanemab.

Per the FDA, the CRL was issued as the study supporting the regulatory filing had limited information on patients who received a minimum of 12 months of continued treatment on donanemab. The CRL specifically requested Lilly to provide data from at least 100 patients with at least 12 months of exposure to donanemab.

The regulatory filing was based on data from the phase II TRAILBLAZER-ALZ study, which evaluated donanemab in patients with Alzheimer's disease (“AD”). While the study did demonstrate amyloid plaque lowering in study participants, Lilly said many patients stopped receiving the drug dosing as early as six months of treatment due to the speed of plaque reduction. This achievement of early amyloid plaque clearance resulted in fewer than 100 study participants receiving donanemab for 12 months.

Based on the responses received in the CRL, Lilly will work closely with the FDA to evaluate the fastest pathway to resolve the FDA’s queries. Per management, this will not impact the financial guidance for 2023 issued by the company last month.

A late-stage TRAILBLAZER-ALZ 2 study is currently ongoing, which is expected to act as a confirmatory study supporting the traditional approval for donanemab in AD indication. Despite the CRL, management expects to report topline data from the study later this year and file for standard approval by mid-2023.

Shares of Eli Lilly were down 1.2% on Jan 20 in after-market trading following the announcement. This setback would likely delay the commercial introduction of donanemab by several months. The stock has gained 44.4% in the year compared with the industry’s 13.8% rise.

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The AD target market is highly competitive as several other pharma companies like Anavex Life Sciences (AVXL - Free Report) , Biogen (BIIB - Free Report) and Roche (RHHBY - Free Report) have their drugs targeting the AD indication. The Alzheimer’s drugs of these companies have either recently been approved for use or are in late-stage development.

Earlier this month, the FDA approved Biogen/Eisai’s Leqembi (lecanemab) under the accelerated approval pathway for the treatment of early AD. The approval was based on data from a mid-stage study which showed that treatment with the Biogen drug reduced the accumulation of amyloid beta (Aβ) plaque in the brain. Biogen/Eisai priced Leqembi at a wholesale acquisition cost (WAC) of $26,500 per year.

Last November, Rocheannounced the failure of the GRADUATE I and II studies, evaluating its monoclonal antibody gantenerumab in early AD. The studies failed to meet their primary endpoint of slowing clinical decline. Patients treated with Roche’s gantenerumab showed a slowdown of clinical decline in GRADUATE I and GRADUATE II, which was not statistically significant. Per Roche, the level of beta-amyloid removal was lower than expected.

Last month, Anavex Life Sciences reported positive topline data from a phase IIb/III study on its lead pipeline candidate ANAVEX 2-73 (blarcamesine) in AD indication. The ANAVEX 2-73-AD-004 study achieved its primary and key secondary endpoints. Data from the study showed that study participants who received ANAVEX 2-73 were 84% more likely to have improved cognition than those who were administered a placebo. Patients treated with ANAVEX 2-73 were 167% more likely to improve function than those receiving a placebo. The treatment also showed a statistically significant reduction in cognitive decline at the end of treatment by 45% compared with the placebo.


Zacks Rank

Eli Lilly currently carries a Zacks Rank #4 (Sell).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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