FDA accepts Fennec’s resubmitted NDA

April 28, 2022

The U.S. FDA has accepted Fennec Pharmaceuticals resubmitted new drug application (NDA) for Pedmark, a drug aimed at preventing hearing loss in children who receive platinum-based chemotherapy.

The drug was originally granted breakthrough therapy and fast track designations by the FDA in March 2018. Then, when the Durham, North Carolina-based Fennec submitted its NDA, the agency replied with a complete response letter (CRL) in August 2020. The CRL pointed out deficiencies seen during an inspection of the manufacturing facility, which had resulted in a Form 483. Fennec then resubmitted its NDA in June 2021 based on the results of two completed phase 3 trials and received yet another CRL in Nov. 2021, due to manufacturing deficiencies. 

Now, the FDA says it will respond to Fennec's most recent submission by September 23, 2022.

“If approved, Pedmark has the potential to become a transformative treatment for pediatric patients at risk of cisplatin induced ototoxicity,” said Rosty Raykov, CEO at Fennec.

Cisplatin is a platinum-based compound that is used in chemotherapy treatment for several childhood cancers. However, these therapies can cause permanent hearing loss for patients, called ototoxicity. Currently, there is no way to prevent or restore hearing loss from chemotherapy aside from cochlear implants.

Over 10,000 children receive platinum-based chemotherapy each year in the U.S. and Europe, according to Fennec.