'Lots of ways for donanemab to win' in Alzheimer's, Lilly says. Now, it just needs the data

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来源: FierceBiotech

The Indianapolis Big Pharma is awaiting a crucial readout from the phase 3 TRAILBLAZER-ALZ 2 study for monoclonal antibody donanemab—a make or break result that investors are impatiently waiting for.

Analysts are desperately trying to read the tea leaves comparing Eli Lilly’s Alzheimer’s disease med and Eisai/Biogen’s Leqembi before the mug is cool, but executives say there are “lots of ways for donanemab to win.”

Lilly executives remain bullish on donanemab’s market potential even with the first-to-market advantage likely taken by Biogen and Eisai.

“This will be a very important and meaningful drug. I know it's interesting for investors to sort of speculate on competition between two different pharma companies. That’s not exactly how I think about it,” Chief Scientific and Medical Officer Daniel Skovronsky, M.D., Ph.D., said during Lilly’s first-quarter earnings call Thursday.

First, Lilly needs to see the data, which are due this half. The Indianapolis Big Pharma is awaiting a crucial readout from the phase 3 TRAILBLAZER-ALZ 2 study for the monoclonal antibody—a make or break result that investors are impatiently watching out for. Lilly was beaten to the market by Eisai and Biogen when Leqembi received accelerated approval in January, later receiving a no for the same early-market access request for donanemab. It’s likely that Eisai will get the full approval before Lilly, which has to wait for the phase 3 TRAILBLAZER data before submitting.

Skovronsky said that, should the late-stage trial confirm earlier phase 2 data showing a 32% slowing of disease progression, “there’s a huge opportunity here for patients.”

“The challenge is not really about competition. It's about how do we help the medical system better identify patients, diagnose them and move them into treatment regimens?” he said. Getting reimbursement from the Centers for Medicare & Medicaid Services is also needed to ensure access. The agency has kept in place a hold on coverage for only patients apart from those participating in clinical trials for Alzheimer’s monoclonal antibodies that are approved under the accelerated pathway.

But donanemab and Leqembi have key differences, Skovronsky noted. Lilly’s offering targets amyloid plaques and can have a fixed duration dosing schedule, meaning patients can in some instances take it and stop. Leqembi, meanwhile, is to be taken for longer.

“Let's see how the data turn out, but I expect that many patients will be able to stop dosing even as soon as 12 months,” Skovronsky said. “That's a big difference than being prescribed a drug that you might have to take the rest of your life. And I think that could be exciting and important for patients.”

“So [there’s] lots of ways for donanemab to win. I think the most important thing though, is showing consistent strong efficacy like we did in phase 2, and then getting this drug approved and bringing it to patients,” he concluded.

Anne White, president of Lilly Neuroscience, said she remains confident in the mid- to long-term markert opportunity for the therapy but reminded investors that “it will take time to build this market.”

“I don't think we really think of this as a class of drugs we need to fight over market share,” White said. “It's an opportunity to build a new class on behalf of people with the disease, driving awareness, driving diagnosis and then getting access. So that's important to us in the near term.”

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