November 2, 2021
Lilly Begins The Application Process For Us Approval Of Donanemab

Eli Lilly and Company’s experimental Alzheimer’s drug,

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Donanemab, is expected to receive a regulatory decision by the second half of 2022, potentially pitting it against Biogen’s Aduhelm which has already received its approval.

Much like Biogen, Lilly has requested accelerated approval for use in early Alzheimer’s disease from the FDA. This regulatory pathway to approval requires a study that confirms the drug works as intended. In addition, Lilly is also conducting a larger, late stage trial and is expecting to see data from that study by mid-2023.

Lilly has also initiated a head-to-head study between Donanemab and Aduhelm to determine which drug is more effective at clearing brain amyloid plaque deposits, which is likely to benefit patients with Alzheimer’s.

“Specialty Rx is always on the lookout for new and innovative treatment options in the pharmaceutical industry and is monitoring these developments closely” stated Saba Ansari -Pharm.D, Operations Specialist at SpecialtyRx.