Fennec Pharmaceuticals Eyes Potential EU Approval of Pedmark to Treat Chemotherapy-associated Hearing Loss in Younger Patients
By Alex Keown
April 6, 2023
Fennec Pharmaceuticals continues to build out its Pedmark commercial team in anticipation of potential approval in Europe following a recommendation for approval from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on March 31.
Pedmark (sodium thiosulfate injection) was greenlit by the FDA in September 2022 as the first and only therapy to reduce chemotherapy-associated hearing loss in pediatric patients (<18 years of age). Specifically, Pedmark was approved to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors. Once it was approved in the United States, availability of Pedmark was quickly rolled out by the Research Triangle Park-based company.
With anticipation of potential approval in Europe, Fennec continues to build out its commercialization team to support marketing of Pedmark, which will be branded Pedmaqsi for the European market. The company estimates there are approximately 5,000 pediatric oncology patients in Europe who receive platinum-based chemotherapy each year. Of those, an untold number could be impacted by drug-associated hearing loss.
Ototoxicity, a loss of hearing, is a well-documented side effect of platinum-based chemotherapy agents, particularly cisplatin. Although the incidence of ototoxicity depends on the dose and duration of chemotherapy, it is estimated that more than 10,000 children in the U.S. and Europe receive this type of chemotherapy each year. In younger cancer patients, the loss of hearing can negatively impact speech language development and literacy. It can also impact social and emotional development.
“There are currently no approved treatments in Europe to mitigate the risk of permanent and irreversible bilateral hearing loss which occurs in approximately 60% of children treated with cisplatin and can be as high as 90%. The CHMP positive opinion brings European patients and their families closer to having a preventive treatment option to prevent the devastating consequences of hearing loss following the use of cisplatin chemotherapy, an indispensable treatment of choice in many pediatric cancer cases,” Rosty Raykov, chief executive officer of Fennec Pharmaceuticals said in a statement.
As 2023 rolls on, Raykov said the company will continue to expand its prescriber base to increase the availability of Pedmark for pediatric patients. In January 2023, Pedmark was included in the National Comprehensive Cancer Network’s treatment guidelines for adolescent and young adult oncology.
That was followed by an FDA decision to grant Orphan Drug exclusivity to Pedmark. That decision provides Fennec with seven years of market exclusivity for Pedmark. The designation also includes a designation that Pedmark is not to be substituted with other sodium thiosulfate products.
“We are very proud of Fennec’s patient-centric approach and the performance across the entire organization, and we continue to be motivated by the positive responses that we are receiving from the pediatric cancer patient community, healthcare providers and payors,” Raykov said in a company statement.
Pedmark was approved based on data from two open-label, randomized Phase III clinical studies.
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Alex Keown is a freelance journalist who writes about a variety of subjects including the pharma, biotech, and life science industries. Prior to freelancing, Alex has served as a staff writer and editor for several publications.
