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The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. Eisai/Handout via REUTERS/File Photo Acquire Licensing RightsBOSTON, Oct 25 (Reuters) - An injected version of Eisai (4523.T) and Biogen's (BIIB.O) Alzheimer's drug Leqembi works as well as the current intravenous version at removing toxic brain plaques, according to an analysis presented by Eisai on Wednesday. The Japanese drugmaker's review compared data for 72 patients with early Alzheimer's given Leqembi by subcutaneous injection to prior pivotal trial results from 898 patients who received the drug by infusion. Blood concentration levels of the drug were 11% higher with subcutaneous Leqembi than the IV version. Roll-out of IV Leqembi, which has an annual list price of $26,500, has been slow.

Persons: Eisai, Leqembi, ”, Eric Reiman, Priya Singhal, Biogen, Michael Irizarry, Alzheimer's, Julie Steenhuysen, Deena Beasley, Bill Berkrot, Leslie Adler Organizations: Reuters, REUTERS, Rights, Banner Alzheimer's Institute, ARIA, Thomson Locations: Handout, Boston, Los Angeles

The drug, donanemab, met all goals of the trial. "These are the strongest phase 3 data for an Alzheimer's treatment to date," said Maria Carrillo, chief science officer for the Alzheimer's Association. In the donanemab treatment group, Lilly said brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. In the Leqembi Phase 3 trial, the drug was associated with brain swelling in nearly 13% of its study participants. It also said 47% of donanemab patients in the 18-month trial had no disease progression at 12 months, compared with 29% of the placebo group.

☆ 'It totally backfired': The pitfalls of Alzheimer's genetic testing
▼ + stars: | 2023-04-21 | by ( Julie Steenhuysen | ) www.reuters.com time to read: +8 min

CHICAGO, April 21 (Reuters) - Wendy Nelson watched her mother slowly die of Alzheimer's disease, unable to move or swallow at the end. When her father's memory began to fail a year later, one of her two sisters doubted it could be Alzheimer's, Nelson said. THE TESTING REVOLUTIONUntil recently, most doctors tended not to order genetic tests to determine Alzheimer's risk, because there were no effective treatments to slow or prevent the disease. US regulators recommend genetic testing before starting treatment with Leqembi. Some members of families with increased genetic risk of Alzheimer's say it might be better not to know at all.

☆ Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer's drug
▼ + stars: | 2023-01-19 | by ( Deena Beasley | ) www.reuters.com time to read: +3 min

REUTERS/Mike SegarJan 19 (Reuters) - 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. That study, Lilly said, would form the basis of donanemab's application for traditional FDA approval shortly thereafter. The FDA can grant "accelerated" approval to drugs based on their impact on a measurement, in this case amyloid brain plaques, likely to correlate with patient response. Donanemab is in the same class as aducanumab and lecanemab, the latter being a treatment for early Alzheimer's that was given accelerated approval by the FDA earlier this month. Sales of amyloid-lowering Alzheimer's drugs, which need to be given by infusion, are expected to be minimal until they receive standard FDA approval.

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