3 februari, 2021
AcuCort AB (Spotlight Stock Market: ACUC) today announced that the Swedish Medical Products Agency has granted the company’s drug ISICORT® the indication – treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents who need supplemental oxygen treatment.
In October 2020, ISICORT® received marketing approval in Sweden by the Swedish Medical Products Agency (MPA) for the indications, among others, for the treatment of severe and acute allergic reactions, croup in children, as well as chemotherapy-induced nausea and vomiting (CINV). Based on published positive results from treatment of COVID-19 patients with dexamethasone, AcuCort has applied for and has now been granted an extension of the indication area to also include treatment of coronavirus disease 2019 (COVID-19) in adults and adolescents who need supplemental oxygen treatment.
“We are very pleased that the Swedish Medical Products Agency has approved ISICORT® so quickly for the treatment of COVID-19 patients. This decision means that the healthcare providers will have the opportunity to treat patients undergoing oxygen treatment with AcuCort’s drug ISICORT®. The COVID-19 indication will also be included in our upcoming applications for marketing approval in more markets. The positive decision strengthens us in our partner dialogues and efforts to commercialize ISICORT®. These activities continue as planned,” says Jonas Jönmark, CEO of AcuCort AB.
ISICORT® is a patented thin, fast-dissolving and user-friendly oral film. The fast-dissolving oral film contains the glucocorticoid dexamethasone which is a well-known, often used and well-documented anti-inflammatory substance.
This information is information that AcuCort AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person below, on February 3, 2021.
For more information, please contact
Jonas Jönmark, CEO, AcuCort AB
Telephone: + 46 (0)70 365 5400
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), as well as coronavirus disease 2019 (COVID-19) in adults and adolescents who need supplemental oxygen treatment. The bioequivalence study that forms the basis of the application for marketing approval in Europe was carried out with positive results and the Swedish national application was approved by the Swedish Medical Products Agency in October of 2020. 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