US pharmaceutical giant Eli Lilly's new drug for treating Alzheimer's disease has cleared obstacles to its US listing, with its stock price narrowing sharply during trading hours.
During the midday session on Tuesday, July 2nd, US Eastern Time, Eli Lilly &amp; Co., which had fallen more than 3.9% in the morning session to refresh its daily low, accelerated its rebound, narrowing its intraday decline to less than 1%, briefly falling only 0.26%.
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During the midday session on Tuesday, the US regulatory agency, the Food and Drug Administration (FDA), officially approved Eli Lilly's new drug, donanemab, for the treatment of early-stage Alzheimer's disease (AD) in adult patients. Approval means that Eli Lilly can sell this new drug in the US under the brand name Kisunla donanemab, making it the second approved drug in the US to treat brain atrophy diseases.
This FDA approval is based on a large-scale Phase III double-blind placebo-controlled trial. The trial included 1,736 early-stage AD patients who received donanemab, or Kisunla, injections or placebo treatment every four weeks for up to 72 weeks. The primary outcome of the trial was the least squares mean (LSM) change in the integrated AD rating scale (iADRS) score, with lower scores indicating more severe damage. In the low/medium pathological tau population, at 76 weeks, the LSM change in iADRS score relative to baseline was -6.02 for those treated with Kisunla, compared to -9.27 in the placebo group.
Kisunla is a monoclonal antibody intravenous injection with a dose of 350 mg/20 mL once every four weeks, suitable for patients with mild cognitive impairment (MCI) and those in the early stage of mild dementia with confirmed brain pathology of amyloid beta in AD patients. Eli Lilly has priced Kisunla at $695.65 per bottle, with a 12-month treatment cost of $32,000.
Some industry media have pointed out that Kisunla is the world's first and only amyloid-targeted treatment with evidence to support stopping treatment when amyloid plaques in the brain are cleared. This evidence-based conclusion can reduce treatment costs and reduce the number of drug injections.
Some media comments that the approval of Kisunla is a huge victory for Eli Lilly and its investors. Over three years ago, this drug showed promise in treating AD in clinical trials, and investors have been eagerly awaiting its market launch since then, with regulatory authorities delaying approval multiple times during this period. Approval also signifies the availability of a second drug on the market that can slow the onset of brain diseases in 6 million Americans.
The approval of Kisunla this time was not unexpected. Three weeks ago, on June 10th, the FDA's expert committee unanimously approved the drug's effectiveness with 11 votes, and also 11 votes in favor of recognizing that the benefits of the drug outweigh the risks, including ARIA side effects
The efficacy data is as follows: after 76 weeks of treatment, iADRS decline was delayed by 22%, and CDR-SB score decline was delayed by 29%.
At that time, the media pointed out that after Kisunla was approved, it would directly compete with Leqembi, a drug jointly developed by Eisai Co. and Biogen, which was launched in the United States early last year. Leqembi is also suitable for early AD patients, namely AD patients with mild cognitive impairment or in a mild dementia state.
After Kisunla was approved this Tuesday, Lilly narrowed its intraday decline, while Biogen hit a new daily low at midday, with the intraday decline expanding to nearly 2.9%.
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The US FDA has approved Eli Lilly's donanemab under the brand name Kisunla for sale in the United States to clear obstacles, making it the second drug to slow down brain atrophy disease to be marketed in the US. The developer of its US competitor Leqembi, Bojian, saw a drop of nearly 3% in midday trading

New Alzheimer's drug approved in the US, Eli Lilly narrows intraday decline by over 3%