2022-09-22| Trials & Approvals

Fennec’s PEDMARK Finally Gains FDA Approval to Treat Chemo-Induced Hearing Loss

by Reed Slater
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Fennec Pharmaceuticals announced that its chemotherapy-induced hearing loss treatment, PEDMARK, received FDA approval after decades of development and two prior New Drug Application (NDA) submissions. The approval marks the company’s first approved product in its 26-year lifespan and five years since it went public. 

Reaching the Light at the End of the Tunnel

PEDMARK received the FDA’s orphan drug designation in 2004 to reduce the risk of ototoxicity associated with cisplatin in patients as young as one month old. Cisplatin and other platinum compounds are used in chemotherapy products, especially ones used to treat malignancies in pediatric patients. Though essential to treatment, the compounds can result in permanent hearing damage in young patients.

Following the orphan drug designation, PEDMARK development remained relatively uneventful for years while Fennec continued to chip away at the research and development of the product. In 2018, the drug’s development hit a major milestone when it received Fast Track Designation, bringing an eventual approval closer than ever. 

Two years after the Fast Track Designation, Fennec submitted PEDMARK’s first NDA with high hopes that the drug would finally make it to market. Unfortunately, the FDA responded with a Complete Response Letter (CRL), denying the NDA based on an undisclosed hitch in the manufacturing process. Undeterred, Fennec worked with the regulatory authority and submitted another NDA a year later, but again, the FDA cited manufacturing issues as the reason for denial

After the two major setbacks in the approval process, Fennec powered through and submitted an NDA for the third time in April this year. After ironing out all the manufacturing issues, the FDA deemed PEDMARK worthy of approval, marking the drug as Fennec’s first and only product on the market. 

Related Article: BridgeBio and Sentynl Therapeutics’ Nulibry Gets Greenlighted In Europe

Positive Trial Results Supporting the FDA’s Decision

The FDA based PEDMARK’s approval on two sets of Phase 3 clinical trials studying the drug’s safety and efficacy in pediatric patients undergoing cisplatin-based chemotherapy. PEDMARK demonstrated positive results and a tolerable safety profile in both clinical trials. 

The first set of trials, SIOPEL 6, enrolled 114 patients and demonstrated fewer incidences of hearing loss with PEDMARK plus cisplatin-based chemotherapy compared to cisplatin-based chemotherapy alone. The other set of trials, COG ACCL0431, presented similar results among a population of 125 participants. COG ACCL0431 demonstrated a difference in hearing loss incidence of 21% with PEDMARK compared to 73% without the drug, and SIOPEL 6 marked a difference of 33% with the drug and 63% without PEDMARK. 

Following a long journey, Fennec has the opportunity to make the difference it has always wanted to with PEDMARK. The drug can finally showcase its potential on a larger scale to reduce the chance of hearing loss in pediatric patients undergoing cisplatin-based chemotherapy. 

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