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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowEli Lilly and Co. said Thursday that it is nearly ready to take another shot at getting regulatory approval for a possible Alzheimer’s drug.
The Indianapolis-based drugmaker plans to submit its potential treatment donanemab to the Food and Drug Administration later this year.
Lilly shares jumped more than 9%, or $19.65, to $236.68 in mid-morning trading Thursday.
The announcement comes a few weeks after the FDA approved a treatment from rival Biogen despite warnings from the agency’s independent advisers that it hasn’t been shown to help slow the brain-destroying disease.
The agency approved Biogen’s Aduhelm based on study results showing it seemed “reasonably likely” to benefit Alzheimer’s patients. It’s the first new Alzheimer’s drug in nearly 20 years and the only therapy that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.
Lilly said Thursday that it will seek approval for donanemab based on data from a mid-stage clinical study of the drug involving 272 patients. The FDA gave donanemab a “breakthrough therapy” designation, which is intended to speed the development and review of drugs that show signs of being an improvement over established treatments.
The Indianapolis company also will examine the drug in a larger, late-stage study. A company spokeswoman said Lilly plans to complete enrollment in that study by the end of the year, and an 18-month treatment period will follow.
Both Aduhelm and donanemab help clear a protein called beta-amyloid from the brain.
Lilly may be able to file its application for approval in the next two or three months since the drugmaker appears to have all the data it needs, said Dr. Vamil Divan, an analyst who covers the company for Mizhuho Securities USA.
Some 6 million people in the U.S. and many more worldwide have Alzheimer’s, which gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks.
Lilly and several other drugmakers have previously failed in attempts to find a treatment that slows the progression of the mind-robbing disease.
More than four years ago, Lilly said another potential drug it developed called solanezumab did not work better than a placebo treatment in a study of over 2,100 people.
That drug also aimed to clear potentially harmful protein from the brain.
Original story (7:14 a.m.):
Eli Lilly and Co. has received “breakthrough therapy” designation for its Alzheimer’s drug donanemab from the U.S. Food and Drug Administration, putting the drug on a path that could expedite its development.
The designation is granted to drugs when preliminary clinical evidence indicates its use may demonstrate substantial improvement over current treatments.
By 7:59 a.m., news of the designation, announced Thursday morning, had boosted the Indianapolis-based company’s stock price by 7% in pre-market trading.
Lilly said it plans to submit a biologics license application for the drug to the FDA through the accelerated approval process later this year.
The application will be based on data from its Phase 2 trial study. The company said the safety, tolerability and efficacy of the drug are being evaluated in an ongoing Phase 3 trial.
Earlier this month, in a landmark decision, the FDA gave approval to another Alzheimer’s treatment developed by Biogen through the accelerated approval process.
After decades of research failures by numerous companies, Biogen’s aducanumab became the first drug cleared by the U.S. Food and Drug Administration to slow the course of the mind-wasting disease that afflicts 6 million Americans.
Analysts have estimated that annual sales of the Biogen drug alone could peak at $5 billion.
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