The newest treatment approved for amyotrophic lateral sclerosis (ALS) will be withdrawn from the market due to negative clinical trial results; former President Trump’s surgeon general is advocating for conservative states to support needle exchanges; new US hepatitis C infections dropped slightly in 2022 after more than a decade of steady increases.
The maker of a drug for Lou Gehrig’s disease that recently failed in a study says it will pull the medicine from the U.S. market. Amylyx Pharmaceuticals said Thursday it will halt marketing in the U.S. and Canada. In March, the drugmaker announced that its drug had failed to show any benefit for patients in a 600-person study. The drug’s failure is a major disappointment for ALS patients and advocates who pressed the FDA to approve it. Amylyx's voluntary withdrawal resolves a potential dilemma for the FDA, which had no way of quickly forcing the drug from the U.S. market. That's because regulators granted the drug full approval in 2022, despite the Cambridge, Massachusetts, company presenting only preliminary study results.
Amylyx Pharmaceuticals announced Thursday it was withdrawing its approved treatment against the deadly neurodegenerative disease ALS after clinical data found no evidence the drug worked. The news follows data from a clinical trial of 664 ALS patients announced in March, which found no significant differences in outcomes between those on the treatment group and those who received a placebo.
The maker of a drug for Lou Gehrig’s disease that recently failed in a study says it will pull the medicine from the U.S. market. Amylyx Pharmaceuticals said Thursday it will halt marketing in the U.S. and Canada. In March, the drugmaker announced that its drug had failed to show any benefit for patients in a 600-person study. The drug’s failure is a major disappointment for ALS patients and advocates who pressed the FDA to approve it. Amylyx's voluntary withdrawal resolves a potential dilemma for the FDA, which had no way of quickly forcing the drug from the U.S. market. That's because regulators granted the drug full approval in 2022, despite the Cambridge, Massachusetts, company presenting only preliminary study results.
The maker of a drug to treat ALS says it will withdraw the medication from the market after it recently failed a large clinical trial. Amylyx Pharmaceuticals…