Tag Archives: drug

Biogen submits BLA for an Alzheimer’s drug with a controversial past

Liz Seegert

About Liz Seegert

Liz Seegert (@lseegert), is AHCJ’s topic editor on aging. Her work has appeared in NextAvenue.com, Journal of Active Aging, Cancer Today, Kaiser Health News, the Connecticut Health I-Team and other outlets. She is a senior fellow at the Center for Health Policy and Media Engagement at George Washington University and co-produces the HealthCetera podcast.

Photo: GollyGforce via Flickr

Could an Alzheimer’s drug finally be on the horizon? Possibly ― if the FDA agrees with data from several Biogen clinical trials ― but approval is still far from a sure bet.

The company, on July 9, submitted its biologics license application (BLA) for aducanumab, an investigational treatment for the disease. The submission includes clinical data from Phase 3 EMERGE and ENGAGE studies, as well as the Phase 1B PRIME study. Biogen has requested an accelerated review, potentially putting the medication on a path for a final decision by March 2021. However, data from these Phase 3 trials are not without controversy in the scientific community.

“Aducanumab, a so-called monoclonal antibody designed to target amyloid plaque in the brain, has been one of the most closely watched drugs in development for several years,” according to Bloomberg News. Continue reading

Alzheimer’s drug puts journalists’ judgment to test

Judith Graham

About Judith Graham

Judith Graham (@judith_graham), is a freelance journalist based in Denver and former topic leader on aging for AHCJ. She haswritten for the New York Times, Kaiser Health News, the Washington Post, the Journal of the American Medical Association, STAT News, the Chicago Tribune, and other publications.

It was the kind of news that had to be handled delicately, with a deft touch and a sense of perspective. A new drug appeared to halt the progression of Alzheimer’s disease for up to three years – a result never achieved before – but only in a handful of patients, according to results of a small study presented at a major international conference.

How did major media do in covering this development?

Marilynn Marchione of The Associated Press was careful not to overplay the findings and fuel speculation that definitive progress against Alzheimer’s had finally been achieved:

“For the first time, researchers are reporting that a treatment might help stabilize Alzheimer’s disease for as much as three years, although the evidence is weak and in only four patients.

“The drug is Gammagard, made by Baxter International Inc. Doctors say that four patients who have been receiving the highest dose for three years showed no decline on memory and cognition tests. A dozen others on different doses or shorter treatment times didn’t fare as well.

“The study was far too small to prove the treatment works, but a more rigorous one involving 400 patients will give results within a year.”

Core Topics
Health Reform
Other Topics

Note what Marchione didn’t do. She didn’t call this a breakthrough. She didn’t suggest that results from this small study were reliable, or that they should give patients or medical practitioners hope. Instead, she was careful to strike a cautionary note from the start – the responsible way to approach this news.

At USA Today, Janice Lloyd took a very different approach:

“Although it’s still in a testing phase, the first long-term treatment shown to halt the progression of Alzheimer’s disease is being hailed Tuesday by experts at the Alzheimer’s Association International Conference 2012 in Vancouver.”

I’m sure this is true – that many experts at the conference indeed “hailed” the study’s findings. But practitioners in this field are primed to enthusiastically welcome any positive development since results of all other studies to date have been bleak. Putting this in the story’s lede gives a wrong first-off impression that this is a seminal event in the fight against Alzheimer’s. (It may be, it may not be; we don’t know yet is the truth of the matter.) Continue reading