ALS Drug Relyvrio Faces Scrutiny After FDA Trial Disappointment!

ALS Drug Relyvrio Faces Scrutiny After FDA Trial Disappointment
ALS Drug Relyvrio Faces Scrutiny After FDA Trial Disappointment. Credit | Getty images

United States: Pharmaceuticals, a pharma company, made an announcement on Thursday that the drug Relyviro is no longer available after it failed to provide adequate support to patients during a late clinical trial, and it ceased to be available for new customers. In Canada, medication was sold as Albrioza.

With the outcome of the clinical trial disappointing, the producer of the drug announced that it decided to remove the drug from the market.

Reason for a rollback of the drug

Joshua Cohen and Justin Klee, co-CEOs of Amylyx, made a statement, “The decision to remove RELYVRIO/ALBRIOZA from the market and provide therapy free of charge for those who wish to continue was informed by the PHOENIX trial results, engagement with regulatory authorities and discussions with the ALS community,” as US News reported.

He further added, “Thank you to each and every person who shared feedback with us and continues to support our commitment to the ALS community.”

Moreover, on Thursday, the company stated, “Patients currently on therapy in the U.S. and Canada who, in consultation with their physician, wish to continue can be transitioned to a free drug program.”

More about the drug

Relyvrio combines two older drugs: treatment of a liver disorder with a prescription drug and a dietary supplement important in traditional Chinese medicine.

According to the New York Times, 4000 patients who are presently using Relyvrio, which has a list price of USD 154,000 per year (the year listing price), reportedly are ALS patients.

The first approval of Relyvrio in the USA was in September of 2022 when the US Food and Drug Administration (FDA) made it after a persisting, intensive effort on the part of ALS patients, which is a terminal affliction with muscle-wasting disease.

Unfortunately, the result of the latest study, which is named by PHOENIX, is that the drug did not work to slow the disease compared with the placebo treatment, and it also did not create improvements in all of the other secondary measures, including muscle strength.

More about ALS

ALS is a corpsing neurodegenerative disease that invades and slowly erodes nerve cells that are vital to performing daily life activities such as walking, speaking, walking, and breathing. The most advanced stage of the disease often results in death within three to five years.

How was Relyvrio approved?

Relyvrio’s approval was mainly due to the fact that the result was derived only from one small study, which was criticized by some scientists working at the FDA.

The same outside experts who at first opposed the drug under pressure from the patients later came to a different decision when the latter asked for a review meeting.

At the time, Amylyx drew attention to the continuing study covering almost 600 people that would give the final results.

However, in a very uncommon act, Amylyx top officials at one of the advisory meetings told the FDA regulators that they would withdraw the drug from the market if follow-up research did not confirm its effectiveness.

It was the FDA’s commitment that seemed to assure their advisers who then voted for the drug approval, despite the questionable data that were at hand.