ALZHEIMERS DRUG APPROVED

News Update

FDA approves first new Alzheimer’s drug in nearly 20 years

By Jimmie Johnson (Reporter), Ben Burke (Producer), Mack Pittman (Editor)

fda new Alzheimers drug

WASHINGTON (AP) — Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease.

The Food and Drug Administration said it granted approval to the drug from Biogen based on results that seemed “reasonably likely” to benefit Alzheimer’s patients.

It’s the only drug that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.

The decision, which could impact millions of older Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.

The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The medication, aducanumab, will be marketed as Aduhelm and is to be given as an infusion every four weeks.

Jimmie Johnson:vNEW TODAY — A LANDMARK MOMENT IN THE FIGHT AGAINST ALZHEIMER’S.
I’M JIMMIE JOHNSON WITH STRAIGHT ARROW NEWS.
THE FOOD AND DRUG ADMINISTRATION APPROVES THE FIRST NEW ALZHEIMER’S DRUG IN TWENTY YEARS.
ADUCANUMAB BY BIOGEN IS THE FIRST TREATMENT TO ADDRESS AN UNDERLYING CAUSE OF THE DISEASE.
HERE’S HOW IT WORKS.
THE DRUG REMOVES STICKY DEPOSITS OF A PROTEIN FROM THE BRAIN OF A PATIENT IN EARLIER STAGES OF ALZHEIMER’S — IN ORDER TO HOLD OFF THE DISEASE’S PROGRESSION.
THE DRUG IS UNDER SOME CONTROVERSY.
IT’S HAILED BY ADVOCATES AND SOME NEUROLOGISTS — BUT OTHER DOCTORS SAY CLINICAL TRIAL RESULTS ARE INCONSISTENT — AND MORE PROOF IS NEEDED.
THE F-D-A APPROVED THE DRUG UNDER WHAT IS CALLED AN ACCELERATED APPROVAL PROGRAM.
THIS MEANS IT WILL STILL UNDERGO FURTHER STUDY, BUT IT’S AVAILABLE NOW.
THE DRUG WILL BE MARKETED UNDER THE NAME ADUHELM.
FOR MORE DAILY NEWS — STAY WITH US THROUGHOUT THE DAY — RIGHT HERE ON STRAIGHT ARROW NEWS.

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fda new Alzheimers drug

WASHINGTON (AP) — Government health officials on Monday approved the first new drug for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease.

The Food and Drug Administration said it granted approval to the drug from Biogen based on results that seemed “reasonably likely” to benefit Alzheimer’s patients.

It’s the only drug that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.

The decision, which could impact millions of older Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.

The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The medication, aducanumab, will be marketed as Aduhelm and is to be given as an infusion every four weeks.