A Drug Developer's First Experience With Decentralized Trials

By Ed Miseta, Chief Editor, Clinical Leader

When the FDA released new guidance for companies in May, it seemed every drug developer was scrambling to convert its clinical trials to a decentralized approach. Advicenne was no exception.

The France-based company has spent a decade developing treatments for rare kidney diseases. Its lead asset, ADV7103, received a positive opinion from the Committee for Medicinal Products (CHMP) recommending approval for the asset as a treatment for distal renal tubular acidosis (dRTA) in the European Union. Trials for the asset are underway in Europe, the U.S., and Canada.