An Eli Lilly injection regimen expected to make major inroads into the treatment of Alzheimer’s disease has hit an unexpected roadblock at the U.S. Food and Drug Administration (FDA), which monitors trials for new medications. The FDA has called for an advisory panel to go over results from a clinical trial for the drug, donanemab. Eli Lilly had expected to make the treatment available to patients early this year, but the convening of the panel means those plans will have to be shelved for the time being.
“It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the [drug trial] results and put donanemab’s strong efficacy in the context of safety,” said Anne White, the company’s executive vice president, in a statement.
Eli Lilly’s stock dropped $18.02 per share over the course of Friday trading.
The drug has drummed up a lot of excitement because earlier trials have shown to significantly slow the memory and general cognitive decline associated with Alzheimer’s. A medication designed for such treatment, which goes after the substance in the brain that reduces brain function, has been a long-sought tool in the quest to ease the suffering of those affected by the disease.
Regulators might be looking further into the serious side effects of donanemab, which in some cases have included brain swelling and bleeding. Other companies have brought similar treatments to market, but Eli Lilly rival Biogen’s efforts stalled when doctors didn’t prescribe it as often as anticipated. Biogen stopped selling its Alzheimer medication earlier this year.