Manufacturer Of Failed ALS Drug Relyvrio Is Considering Withdrawing It
Though the FDA approved the drug less than two years ago, Amylyx's ALS drug has now failed a large clinical trial. Separately, the FDA is delaying approval for an experimental Alzheimer's drug so it can examine its effectiveness.
The New York Times:
A.L.S. Drug Relyvrio Fails Clinical Trial And May Be Withdrawn From The Market
One of the few treatments the Food and Drug Administration has approved for amyotrophic lateral sclerosis has failed a large clinical trial, and its manufacturer said Friday that it was considering whether to withdraw it from the market. The medication, called Relyvrio, was approved less than two years ago, despite questions about its effectiveness in treating the severe neurological disorder. (Belluck, 3/8)
Stat:
Amylyx ALS Drug Failure Raises Questions And Concerns
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. (Feuerstein and Garde, 3/8)
AP:
FDA Will Take A Deeper Look Into The Safety And Effectiveness Of Lilly Experimental Alzheimer's Drug
Federal regulators put off a decision on whether to approve an Eli Lilly Alzheimer’s drug by making an unusual request to have outside advisers look at the treatment. Lilly had expected the Food and Drug Administration to decide on donanemab’s approval by the end of the month. But the drugmaker said Friday that the agency now wants more information about its safety and effectiveness. No date has been set for the advisory committee meeting. (Murphy and Perrone, 3/8)
The New York Times:
Overdose Or Poisoning? A New Debate Over What To Call A Drug Death
As millions of fentanyl-tainted pills inundate the United States masquerading as common medications, grief-scarred families have been pressing for a change in the language used to describe drug deaths. They want public health leaders, prosecutors and politicians to use “poisoning” instead of “overdose.” In their view, “overdose” suggests that their loved ones were addicted and responsible for their own deaths, whereas “poisoning” shows they were victims. (Hoffman, 3/11)
Fortune:
Mark Cuban Says CEOs Don’t Understand Their Health Care Costs. Here’s What The Cost Plus Drugs Cofounder’s Mistakes Have Taught Him
When a CEO fails to grasp the nuances of their company’s health care costs, it’s not just the bottom line that suffers. Employee efficiency and productivity could plummet, too, not to mention the corrosion of company culture. For these reasons, billionaire entrepreneur and Cost Plus Drugs cofounder Mark Cuban urges business leaders to take a hard look at how their health dollars are spent. (Leake, 3/8)
