Eli Lilly & Co.’s bid for accelerated approval of its Alzheimer’s drug donanemab was rejected by US regulators, an sudden setback for the drugmaker.
The Meals and Drug Administration despatched the corporate a full response letter, saying it might not grant early approval for the drug as a result of not sufficient sufferers within the examine had obtained it for a full 12 months, Lilly mentioned in a Thursday publication Rationalization.
The company needed Lilly to offer security knowledge from at the least 100 sufferers who had been taking the drug for a yr. Lilly’s request for accelerated approval was primarily based on a comparatively small, mid-stage examine that allowed some sufferers to discontinue remedy after about six months.
“Different defects weren’t discovered,” mentioned the corporate.
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The setback won’t have an effect on the corporate’s 2023 monetary steerage or its plans to file for normal approval of the drug later this yr if an ongoing late-stage trial is profitable, Lilly mentioned. The corporate expects these leads to the second quarter.
Lilly shares fell as a lot as 1.9% on the New York inventory market open.
Little income impression
It was by no means anticipated that accelerated approval would result in vital gross sales. The U.S. Medicare program has indicated it will not present full protection for amyloid-lowering Alzheimer’s medication like donanemab with out full FDA approval.
Nonetheless, Lilly officers had hoped to get approval for the drug quickly. Rival Eisai Co. and accomplice Biogen Inc. obtained accelerated approval for his or her amyloid-lowering drug Leqembi earlier this month and have already utilized for full approval.
“It is an uncommon state of affairs,” mentioned Daniel Skovronsky, Lilly’s chief scientific and medical officer, in an interview. The corporate’s drug was fairly efficient at eradicating amyloid within the mid-stage of the examine, he mentioned. Some sufferers stopped taking it after just a few months as a result of their amyloid ranges had dropped so low. Others, slower to reply, continued for greater than a yr. If the drug had been much less efficient, the corporate wouldn’t have confronted this drawback, he mentioned.
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Hopes for donanemab had been excessive after an earlier evaluation of the examine confirmed the drug slowed cognitive decline by 32%. Nevertheless, the contributors additionally had a 39 % fee of mind swelling or bleeding in comparison with eight % of the placebo sufferers. In the meantime, Eisais Leqembi slowed cognitive and useful decline by 27%. This drug obtained accelerated FDA approval as a result of its capacity to decrease amyloid.
“The precedence, in fact, is to get conventional approval,” mentioned Skovronsky, who did not rule out that the corporate might nonetheless return and apply for accelerated approval as soon as it has obtained extra security knowledge. “Every part relies on our section three examine.”
On Friday, Lilly and Boehringer Ingelheim reported extra information from the FDA, saying the regulator had accepted an extra utility for a brand new drug for Jardiance. The diabetes drug, one in all Lilly’s greatest sellers, is at present being examined to cut back the danger of kidney illness development and heart-related deaths in grownup sufferers with persistent kidney illness.
—With assist from Jonathan Roeder.
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