United States: The eventual pull out of an Amyotrophic lateral sclerosis drug from the market following clinical trials with disappointing outcomes may elicit consequences that go beyond the patients and pharmaceutical industry.
On Friday, Amylyx Pharmaceuticals, the makers of Relyivrio drug which was considered a breakthrough revealed deep sadness that the drug had shown no significant result in the Phase 3 test which was run in a large group of patients.
The company confirmed its intention to withdraw the drug, known as Albrioza in Canada, from the market without elaborating further.
What more did the Executives say?
In a release, the company stated, “Amylyx intends to share comprehensive plans for Relyvrio/Albrioza in ALS, which may include voluntarily withdrawing Relyvrio/Albrioza from the market.”
US News reported that “At this time, Relyvrio/Albrioza and its related patient support program will continue to be available for people living with ALS. Amylyx has voluntarily decided to pause the promotion of the medication during this time.”
Moreover, the executives added that they were “surprised and disappointed” by the results. Following this, they will announce their plans for the drug within the next two months.
Know more about the history of ALS drug
Relyvrio has been licensed by the Food and Drug Administration of the United States for medical purposes since September 2022 after a long campaign carried out by patient advocates deprived of life caused by ALS, a combination of diseases in which the muscles deteriorate.
Unfortunately, the company’s latest studies did not find that the drug slowed the disease compared to its control or lack of treatment, nor did it produce any improvements in secondary measures, such as muscle strength.
ALS is a terrible neurological disorder that progressively destroys all the nerve cells and nerve connections necessary to walk, talk, breathe, and speak in the usual way. The majority of patients with cancer die within three to five years after receiving the diagnosis.
Relyvrio’s approval was mainly based on the results of a small study, which some FDA scientists criticized.
However, an expert committee that was not part of the group of experts at first voted against the drug, but a follow-up meeting requested by the patients led the same committee to adopt a different stand, as US News reported.
During that time, Amylyx disclosed that it was still conducting a follow-up study of more than 600 patients, for which additional data would be provided.
Decision by makers to pull the drugs from market
In contrast to common practices, Amylyx executives told FDA regulators in the advisory committee that they would stop marketing the drug if the subsequent research doesn’t verify its efficacy.
In addition, Amylyz has periodically faced opposition regarding pricing the drug at USD 158,000 for a year’s supply, according to the Associated Press. Furthermore, sales have been weak since the drug launch in 2022.
Relyvrio combines two older drugs: a prescription drug for liver problems and a dietary supplement that is linked with classic Chinese medicine.