Clene plans CNM-Au8 filing for accelerated approval in ALS
WHY IT MATTERS
If CNM-Au8 receives accelerated approval, ALS patients could gain access to a new treatment option sooner than through the standard FDA review timeline, potentially slowing disease progression.
A company called Clene is planning to ask the FDA to approve a new drug called CNM-Au8 for treating ALS, a disease that affects nerve cells and causes muscle weakness. The company met with the FDA and decided to use a faster approval process called accelerated approval, which can get promising treatments to patients more quickly than the standard process.
Following a recent meeting with the U.S. Food and Drug Administration (FDA), Clene is planning to submit an application asking the agency to approve its experimental therapy CNM-Au8 as a treatment for amyotrophic lateral sclerosis (ALS). The company specifically plans to file a new drug application (NDA) seeking accelerated approval, a pathway that allows the […] The post Clene plans CNM-Au8 filing for accelerated approval in ALS appeared first on ALS News Today .