Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration had rejected accelerated approval of its experimental Alzheimer's drug because it had not submitted enough trial data from patients who were treated for at least a year.
Lilly said the FDA had sent it a complete response letter for donanemab, an antibody designed to remove amyloid protein plaques from the brains of people with early Alzheimer's. Such letters typically outline concerns and conditions that must be addressed to gain U.S. approval.
"I don't think it says anything negative about the drug. It was just a manifestation of the study design," said Dr. Ronald Petersen, an Alzheimer's expert at the Mayo Clinic in Rochester, Minnesota. "I don't see this is an impediment to the process or timeline in any way," said Dr. Eric Reiman, executive director of Banner Alzheimer's Institute. "When the Phase 3 trial reads out, I understand it will have that safety data in at least 100 people."
Indonesia Berita Terbaru, Indonesia Berita utama
Similar News:Anda juga dapat membaca berita serupa dengan ini yang kami kumpulkan dari sumber berita lain.
FDA rejects Eli Lilly's proposed Alzheimer's treatment, says more data neededThe setback could delay a potential commercial introduction of the highly anticipated drug by at least several months, if the Food and Drug Administration...
Baca lebih lajut »
Eli Lilly announces details on plans for development in Lebanon's LEAP DistrictThe development of the campus will encompass just over 1.6 million square feet, including two three-story 330,000-square-foot peptide manufacturing facilities.
Baca lebih lajut »
Giants legends see Eli Manning in Daniel Jones as they endorse long-term dealJones is finishing up the four-year contract he signed after the Giants made him the No. 6-overall pick in the 2019 draft.
Baca lebih lajut »
Ex-CEO says Biogen shot itself in foot with Alzheimer's drug priceFormer CEO says Biogen 'shot themselves in the foot' by deciding to charge $56,000 for its controversial Alzheimer's drug
Baca lebih lajut »
Dementia: Brain check-up tool aims to cut risk at any ageYou are never too young to start improving your brain health, an Alzheimer's charity says.
Baca lebih lajut »