Newly Approved ALS Drug Priced At $158,000 Annually
Amylyx Pharmaceuticals revealed its recently FDA-approved Relyvrio drug would cost about $12,500 per 28-day prescription. The drugmaker noted it would give the drug free to certain uninsured patients. Separately, reports say the "Ice Bucket Challenge" actually helped fund Relyvrio's development.
Reuters:
Amylyx Prices Newly Approved ALS Drug At $158,000 Per Year
Amylyx Pharmaceuticals Inc on Friday set the list price of its newly approved drug to treat amyotrophic lateral sclerosis (ALS) at about $158,000 per year in the United States, a discount to its most recently approved competitor. The drug Relyvrio was approved by the U.S. Food and Drug Administration on Thursday, making it the third ALS treatment to get the regulator's nod after Japanese firm Mitsubishi Tanabe's Radicava, priced at around $170,000 per year, and the generic drug riluzole. (Leo, 9/30)
Axios:
New ALS Treatment Sparks Yet Another Drug Pricing Debate
The FDA's expedited approval of a new ALS treatment priced at $158,000 a year, has touched off another debate over balancing regulation with patient access. (Owens, 10/3)
AP:
NIH To Fund Unproven ALS Drugs Under Patient-Backed Law
When patients with a deadly diagnosis and few treatment options have tried to get unapproved, experimental drugs, they have long faced a dilemma: Who will pay? Responsibility for funding so-called compassionate use has always fallen to drugmakers, though many are unwilling or unable to make their drugs available for free to dying patients. After years of lobbying Congress, patients with the debilitating illness known as Lou Gehrig’s disease have found an unprecedented solution: make the federal government pay. (Perrone, 10/1)
NPR:
ALS Ice Bucket Challenge Helped Fund The Development Of A New Drug For Treatment
The ALS Association said that $2.2 million of funds that were raised from the Ice Bucket Challenge went into funding the development and trial of the new drug that the Food and Drug Administration approved this week for treatment of ALS, which is also known as Lou Gehrig's disease. (Davis, 10/1)
In other pharmaceutical and biotech news —
Stat:
Epic Overhauls Popular Sepsis Algorithm Criticized For Faulty Alarms
Epic Systems has revamped its widely criticized sepsis prediction model in a bid to improve its accuracy and make its alerts more meaningful to clinicians trying to snuff out the deadly condition. (Ross, 10/3)
Stat:
Scientists Train An AI Model To Predict Breast Cancer Risk From MRI Scans
A biopsy that turns out to have benign results can be a relief. But in some cases, it could also mean a patient whose risk of cancer was low from the start has gone through an unnecessarily invasive procedure. (Williamson-Lee, 10/3)
Reuters:
Walmart, CVS Must Face Lawsuit Over Placement Of Homeopathic Products
The District of Columbia’s highest court revived two lawsuits that claim CVS and Walmart are misleading consumers by selling unproven homeopathic products alongside FDA-approved over-the-counter medicines on their store shelves and websites. (Grzincic, 9/30)
