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Photo: Victor J. Blue/Bloomberg via Getty Images

Eli Lilly plans on filing an application for an "accelerated approval" of its experimental Alzheimer's treatment, donanemab, with the FDA later this year, the pharmaceutical company said today.

Why it matters: The FDA possibly set a new precedent for more unproven Alzheimer's drugs to gain the agency's stamp of approval, after it gave a controversial conditional approval to Biogen's Alzheimer's drug earlier this month.

The big picture: The FDA approved Biogen's drug, Aduhelm (also known as aducanumab), even though the drug failed one of its late-stage clinical trials. The other trial showed a decline in "brain amyloid plaques," which the FDA said could possibly help fight Alzheimer's.

  • Eli Lilly's drug hasn't even completed one late-stage trial. One late-stage trial is ongoing, with results expected in 2023, and another will start enrolling patients this year. A small phase 2 trial studying donanemab found a decline in amyloid.

Shot: "The history ... of the FDA is that it requires two well-controlled studies for an approval, and we believe that's still the case and should be the case," Eli Lilly's CFO Anat Ashkenazi said at an investor conference in May, when asked about filing for FDA approval of donanemab. "If anything changes in two weeks that we learn about, then we'll continue these conversations with the FDA."

Chaser: "The path for accelerated approval shouldn't be present there just for one drug. That should be a new regulatory standard," Dan Skovronsky, Eli Lilly's chief scientific officer, said at an investor conference last week after the FDA approved Aduhelm.

The bottom line: In approving Aduhelm, the FDA made it much more likely that it will approve any experimental Alzheimer's drug that removes amyloid, even if there are safety concerns.

  • Ronny Gal, a pharmaceutical analyst at Bernstein, said his team spoke with Eli Lilly executives this morning, and "they are internally confident they meet the bar set by Aduhelm" even though there is still no late-stage trial data on donanemab.

Go deeper

FDA needs more time on Juul e-cigarette ban decision

The Food and Drug Administration said Thursday it will delay its decision on top-seller Juul, but thousands of other electronic cigarettes will be ordered off the U.S. market.

Why it matters: The stalled decision prolongs the agency's determination on whether there is enough data to show if adult cigarette smokers switching to a less harmful option outweighs the detrimental costs of young people getting hooked on nicotine by vaping.

Sep 10, 2021 - Health

FDA "will follow the science" to approve COVID vaccine for kids under 12

A nurse gives a boy a dose of the Pfizer vaccine at a clinic. Photo: Paul Hennessy/SOPA Images/LightRocket via Getty Images

The FDA said on Friday that it is "working around the clock" to support the process of making the coronavirus vaccine available for children under the age of 12.

Why it matters: The number of children getting hospitalized due to the virus is increasing, with some infectious disease doctors worrying that the Delta variant could be causing more serious illness in kids.

Ben Geman, author of Generate
48 mins ago - Energy & Environment

China vows end to building coal-fired power plants abroad

Chinese President Xi Jinping. Photo: Mary Altaffer - Pool/Getty Images

Chinese President Xi Jinping told the United Nations General Assembly Tuesday that his country "will not build new coal-fired power projects abroad" and plans to boost support for clean energy in developing nations.

Why it matters: The pledge, if maintained, would mark a breakthrough in efforts to transition global power away from the most carbon-emitting fuel.