11 maj, 2020
AcuCort AB (Spotlight Stock Market: ACUC) has completed the reply dossier in response to the Primary Round Assessment Report from the Swedish Medical Products Agency (MPA), regarding the national Market Authorization Application (MAA) for ISICORT®. The reply dossier was submitted as planned on May 8th.
As reported on February 13th 2020, AcuCort received the Primary Round Assessment Report including an overview and question list from the Swedish Medical Products Agency (MPA) in February. The Primary Round Assessment is the first formal step after Market Authorization Application (MAA), towards product approval. There were no major objections in the Assessment Report, and the continued analysis and work answering the question list has not revealed any significant obstacles. The reply dossier has now been submitted on the requested reply date. The MPA will review the reply dossier for 55 days.
“It is with great satisfaction we submit the formal response dossier to the authority regarding ISICORT® market application. As communicated earlier, there were mostly topics concerning the drug product manufacturing, since this is a fairly novel administration type. Our manufacturing partner Adhex Pharma, in France, has been of excellent help in preparing process descriptions and similar information needed, as well as our regulatory expertise partner ProPharma Group. We are happy to conclude that the work could be performed in a good and efficient way, not troubled by the virus pandemic situation,” says Ann Gidner, CEO of AcuCort AB.
For more information, please contact:
Ann Gidner, interim CEO, AcuCort AB
Phone: +46 (0)72 315 1414
About AcuCort AB (publ)
AcuCort develops and commercializes ISICORT®, a new fast-dissolving oral film to put on the tongue, based on a well-known cortisone substance – dexamethasone. ISICORT® is a smart product in a new, innovative, patented and user-friendly dosage form primarily for the treatment of severe and acute allergic reactions, croup in children and chemotherapy-induced nausea and vomiting (CINV). The bioequivalence study that forms the basis of the application for marketing approval in Europe was carried out with positive results and a national hybrid application has been submitted to the Swedish Medical Products Agency. Altogether, this strengthens the company’s assessment that the time to commercialization of ISICORT® may be relatively short. AcuCort (ticker: ACUC) is listed on the Spotlight Stock Market in Sweden. Please visit www.acucort.com.