Robert Besser
04 Dec 2022, 08:04 GMT+10
WASHINGTON D.C.: According to trial data contained in a report presented this week, an experimental Alzheimer's drug from Eisai and Biogen, lecanemab, slowed cognitive decline, but could cause serious side effects for certain patients.
In the 18-month trial involving nearly 1,800 participants with early-stage Alzheimer's, Lecanemab was possibly the cause of a dangerous type of brain swelling in nearly 13 percent of patients.
Five patients also suffered from macrohemorrhages and 14 percent from microhemorrhages, which could have caused two deaths in a follow-on study.
In September, the two companies said that lecanemab, an antibody designed to remove sticky deposits of a protein called amyloid beta, reduced the rate of cognitive decline on a clinical dementia scale (CDR-SB) by 27 percent, compared to a placebo.
However, Dr. Ronald Petersen of the Mayo Clinic in Rochester, Minnesota said, "All of these amyloid-lowering drugs carry a risk for increased brain hemorrhage."
The data confirms the drug "can meaningfully change the course of the disease," said the Alzheimer's Association, calling on U.S. regulators to approve the company's application for accelerated approval.
Detailed data from the study was presented at the Clinical Trials on Alzheimer's Disease meeting in San Francisco.
The U.S. Food and Drug Administration (FDA) will decide whether to approve lecanemab under its "accelerated" review program by 6th January. However, Eisai will soon file for standard FDA approval of the drug and will also seek approval in Europe and Japan, regardless of the FDA's decision.
Get a daily dose of California Telegraph news through our daily email, its complimentary and keeps you fully up to date with world and business news as well.
Publish news of your business, community or sports group, personnel appointments, major event and more by submitting a news release to California Telegraph.
More InformationPhoto credit: Ercin Erturk / Anadolu AgencyThe death toll from Monday's massive 7.8 magnitude earthquake in Turkey and Syria has ...
WASHINGTON D.C.: In a sign of future political battles over record numbers of illegal crossings under Democratic President Joe Biden, ...
MOSCOW, Russia: Russian state-run TASS news agency has reported that a US woman was detained and fined by a Russian ...
ISLAMABAD, Pakistan - Former President General (retd) Pervez Musharraf died in a Dubai hospital on Sunday at the age of ...
JERUSALEM - Israel on Sunday announced plans to build a new town on the Gaza border .The town, temporarily named ...
CHICAGO, Illinois: After an ice storm ravaged states from Texas to West Virginia, this week, airlines canceled over 1,800 flights ...
WASHINGTON D.C.: Despite the efforts of the Federal Reserve Bank to cool the job market to help curb record-high inflation, ...
NEW YORK, New York - A sharp rise in U.S. Treasury yields kept buyers at bay on Wall Street on ...
WASHINGTON D.C.: A report released this week detailed how, in January, layoffs in the US reached a more than two-year ...
PARIS, France: Following an 18 month controversy that exposed the workings of the global jet market, Airbus and Qatar Airways ...
TOKYO, Japan: Japan is preparing to revise legislation to allow it to restrict the export of advanced semiconductor manufacturing equipment ...
LONDON, England: Energy giant Shell Oil has announced a record profit of nearly $40 billion in 2022, capping an eventful ...