hotspot -WSS

hotspot

author：Wikipedia 2025-08-26 02:48:25 - browse：286

This image provided by Amylyx Pharmaceuticals shows the drug Relyvrio. The maker of a much-debated drug for Lou Gehrig’s disease said Friday, March 8, 2024 its therapy failed to help patients in a large follow-up study, but stopped short of committing to follow through on a prior pledge to pull the drug from the U.S. market. — Relyvrio, an ALS drug made by Amylyx Pharmaceuticals, failed to beat placebo in a key clinical trial. Amylyx Pharmaceuticals via AP

The latest disappointment in amyotrophic lateral sclerosis research brought crushing news for patients and physicians, forcing the community to consider just what to do with an approved medicine that doesn’t appear to work.

Amylyx Pharmaceuticals’ announcement Friday that its drug, marketed as Relyvrio, failed to beat placebo in a pivotal study marks “a sad day for us, but we have to believe the data,” said Mary Catherine Collet, an ALS advocate. “These are hard scientific facts that we have to face, and I appreciate that they’re not trying to spin us like some cheerleading practice.”

The question now is whether Relyvrio, approved in 2022, should be removed from the market entirely — and whether the Food and Drug Administration made a mistake by authorizing it in the first place. After years of pressure from patient advocates, the agency has taken a more flexible approach to medicines for devastating, incurable diseases like ALS. But the case of Relyvrio, which made $381 million in sales and $49 million in profit for Amylyx last year, has underlined questions about the limits of regulatory leniency.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Walensky prepares to leave CDC — and Congress — behind
Next article： Trump’s hydroxychloroquine hype: a risk to my treatment and to him

knowledge

WSS

Fatty liver disease was alleviated by Lilly’s ‘triple

The best solution to the drug shortages problem

Man killed during FBI raid in connection with threats against Biden, other officials

NIH trials fail to test meaningful long Covid therapies, experts say

Anavex keeps shifting the goalposts in its clinical trials

Wegovy’s successful heart trial raises vital question about weight loss

Wikipedia

hotspot

explore

Continuity nursing helped my family in our darkest PICU moments

A letter from the executive editor: The 2023 STATUS List

The Supreme Court will review a ruling striking down a domestic violence federal gun ban

Why failed clinical trials don’t always spell doom for a new drug

The high cost of giving birth even with insurance

Undocumented workers face uncertainty as immigration law takes effect in Florida

Walensky prepares to leave CDC — and Congress — behind

Twitch streamer Kai Cenat speaks out for 1st time since causing mayhem with Union Square giveaway

As demand for Covid shots wanes, Moderna seeks its next success

Crowdfunding for unproven stem cell procedures spreads misinformation

Wikipedia

Police still searching for prisoner who escaped from NYC hospital

Correcting Robert F. Kennedy Jr.'s vaccine 'facts'

Wegovy’s successful heart trial raises vital question about weight loss

Shkreli is convicted of fraud. Can pharma finally slam the door on him?

'Screen and refer' systems are hurting patients

Police still searching for prisoner who escaped from NYC hospital

explore

hotspot

knowledge

leisure time