Drug manufacturer Amylyx pulls ALS drug Relyvrio from market, citing lack of efficacy

The following is from Public Citizen.

Amylyx Pharmaceuticals said on Thursday that it would withdraw AMX0035 (sodium phenylbutyrate and taurursodiol, sold as Relyvrio) from the market. A large clinical trial recently found that the drug did not provide any benefit to patients with amyotrophic lateral sclerosis (ALS).

ALS, formerly known as Lou Gehrig’s disease, is a neurological disorder that affects motor neurons, the nerve cells in the brain and spinal cord that control voluntary muscle movement and breathing.

In 2022, Public Citizen urged the Food and Drug Administration (FDA) not to approve AMX0035 because the data from a single small clinical trial and its open-label extension study were inconclusive.

According to STAT, Amylyx charged $163,000 a year for AMX0035, leading to $381 million in sales and $49 million in profits in 2023.

The company’s co-CEOs Joshua Cohen and Justin Klee also publicly promised that they would withdraw the drug if further testing failed to show a benefit.

In March 2024, when the results of the large clinical trial were announced, Public Citizen called for the prompt removal of the drug from the market.

“As the FDA should have never approved AMX0035, the company’s announcement that the drug will be withdrawn from the market is welcome news. Although amyotrophic lateral sclerosis is a devastating disease and effective treatments are urgently needed, the FDA’s approval of AMX0035 allowed the company to make tens of millions of dollars of profits from selling a worthless drug for which there was never evidence of efficacy. Patients were duped, individuals and payors needlessly spent hundreds of millions of dollars, and a company was unjustly enriched. All of these consequences were preventable, and the FDA must take steps to ensure they never happen again. The FDA should never approve a drug without clear evidence of efficacy.”

Dr. Robert Steinbrook, Director of Public Citizen’s Health Research Group

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3 thoughts on “Drug manufacturer Amylyx pulls ALS drug Relyvrio from market, citing lack of efficacy”

  1. Alex Niezgodski

    Good article, I would love for you to do a show on two subjects. The first one on how Biden has been flying ILLEGAL immigrants into the US since Jan 20th, 2021. No ID, passport, green card ,visa or vetting in the least and using tax payer money to do so. The other is about a speech Biden gave at a fundraising event where he threatened to beat the crap out of Trump behind the gym. Please look into these and even a foolish threat needs to be handled by the Secret Service. Trump is a candidate and all threats need to be taken seriously!

  2. “The FDA should never approve a drug without clear evidence of efficacy.”

    Or at least the manufacturor shouldn’t have been allowed to bilk people out of $163,000 per year.

    I can see offering hopeless people ANY kind of hope — even fraudulent hope, so long as it isn’t worse than no hope at all. This seems like blatant, premeditated FRAUD.

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