Suzhou Auzone Biological Technology Co., Ltd. has received approval from the US Food and Drug Administration (FDA) to initiate a pivotal clinical study for its edaravone oral preparations in the treatment of amyotrophic lateral sclerosis (ALS). The Chinese company, which has a wholly owned subsidiary in Australia, is planning to file a New Drug Application (NDA) for the drug with the FDA in March of the following year.
Edaravone’s Background and Auzone Bio’s Advantages
Edaravone, a hydroxyl radical scavenger, was originally developed by Japan-based Mitsubishi Tanabe Pharma Corporation. It was first approved in Japan in June 2015 and subsequently gained marketing approval in the US in May 2017 and in China in August 2019. Auzone Bio sees its oral preparations as more advantageous compared to the original injectable form and other generic versions, which are predominantly injections. The company highlights the benefits of its oral preparations in terms of administration convenience and patient compliance.-Fineline Info & Tech
