Feb,11, 2020: Fennec Pharmaceuticals announced it has completed its rolling submission of an NDA to the U.S. FDA for PEDMARK™ (a unique formulation of sodium thiosulfate) for intravenous use and submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sodium thiosulfate (tradename to be determined).
The PEDMARK™ indication requested is for the prevention of ototoxicity induced by the cisplatin chemotherapy in the patients one month to < 18 years of age with localized, non-metastatic, solid tumours.
Fennec’s PEDMARK regulatory submissions follow: The pre-NDA meeting with FDA in the December 2018 after which Fennec initiated a rolling NDA; and pre-submission meetings with the EMA and also an approved pediatric investigation plan (PIP). Both applications are based upon the clinical results from two pivotal Phase 3 clinical trials:
- SIOPEL 6 by the International Childhood Liver Tumor Strategy Group (SIOPEL), with the results published in June 2018 in the New England Journal of Medicine and
- ACCL0431 by the Children’s Oncology Group (COG), with the results published in 2016 in
“Fennec would like to thanks countless parents, children and investigators who were participated in the clinical trials, as well as our dedicated employees who helped us attain this important milestone.
We are well underway with the commercialization readiness activities to support the potential launch of the PEDMARK and our transition to becoming a commercial-stage organization.”
The FDA has a 60-day review period in order to determine whether the PEDMARK NDA is acceptable for filing. PEDMARK has been granted Orphan Drug, Fast Track designations and Breakthrough Therapy from the FDA.
If PEDMARK is approved a priority review, the Prescription Drug User Fee Act (PDUFA) action date is expected in the third quarter of 2020. In the US PEDMARK is proposed by tradename, European tradename is under evaluation.
About PEDMARK™ (Sodium Thiosulfate (STS): Cisplatin and other platinum compounds are necessary chemotherapeutic agents for many pediatric malignancies. unluckily, platinum-based therapies cause ototoxicity, or hearing loss, which is permanent, irretrievable and is particularly harmful to the survivors of the pediatric cancer. In the U.S. and Europe, it is estimated annually that more than 10,000 children may accept platinum-based chemotherapy.
https://fda.einnews.com/pr_news/509436868/fennec-pharmaceuticals-completes-rolling-submission-of-new-drug-application-nda-to-u-s-food-and-drug-administration-for-pedmark-and-also-submits
