Hyloris Provides Additional Information on U.S. FDA Review of NDA Application for the Registration of Maxigesic IV®
Liège, Belgium - 01 July 2022 – 8.00 PM CET - Regulated information - Inside Information - Hyloris Pharmaceuticals SA (Euronext Brussels: HYL) a specialty biopharma company committed to addressing unmet medical needs through reinventing existing medications, today provided additional details about the United States (U.S.) Food and Drug Administration (FDA)’s review of the New Drug Application (NDA) for the registration of Maxigesic IV®.
The FDA has informed Hyloris’ development partner, AFT Pharmaceuticals, via a Complete Response Letter, that it was unable to complete its review of the NDA for Maxigesic IV® and has provided recommendations needed to address the application’s deficiency. Importantly, the agency did not report any issues related to data generated during Maxigesic IV®’s clinical development program, and the deficiency is confined solely to the Quality section of the application dossier, and more specifically to revise a risk assessment of the required leachable compound study.
“We are corresponding with the FDA to address the recommendations highlighted in the letter as soon as possible,” said Stijn Van Rompay, Chief Executive Officer of Hyloris. “Hyloris initially submitted a toxicological risk assessment for all leachable compounds, however, we will need to re-submit this information based on confirmed compounds quantified using validated methods. As previously stated, this request required by the FDA falls well within the parameters of our normal operational budget and can be completed expeditiously, requiring no additional clinical data to be generated. Hyloris remains committed to Maxigesic IV®, and ensuring the product fulfills its commercial potential in the U.S. We will be updating the market on revisions to the U.S. commercialization timeline for this product candidate as we gain more clarity about the FDA’s request.”
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