WASHINGTON, D.C. — The following statement was issued by David Mitchell, a cancer patient and founder and president of Patients For Affordable Drugs, in response to the pricing of Relyvrio following the Food and Drug Administration’s approval of the drug combination to treat amyotrophic lateral sclerosis (ALS):

“The price of the newly approved drug combination Relyvrio to treat ALS — a terrible neurological disease — is yet another clear and powerful example of unjustified high prices set by drug companies that ultimately exploit patients desperate for new treatments.

“Relyvrio is not proven to work, yet the company that makes the drug, Amylyx Pharmaceuticals, has set an annual price of $158,000. Independent reviewers say the upper limit of a reasonable price would be $30,700 with the important caveat: “if the therapy actually works.”

“This is not a new drug that required years of expensive, high-risk research in a lab; Relyvrio is a combination of two old drugs. It was approved based on a small trial of 137 patients over 24 weeks, not an expensive, large, long study.

“There is no justification for pricing Relyvrio, a drug that has not been proven effective, at $158,000. It is a poster child for what is wrong with drug pricing in America and why our system must be reformed to arrive at appropriate prices that maximize accessibility and affordability for drugs that are shown to be both safe and effective.”

Background

• Last week, the FDA approved Relyvrio, a drug combination to treat ALS even though “the agency’s analysis concluded there was not yet sufficient evidence that the medication could help patients live longer or slow the rate at which they lose functions like muscle control, speaking or breathing without assistance.”