175 0 Kommentare Advicenne Receives Positive CHMP Opinion Recommending Approval of ADV7103 (sibnayal) for the Treatment of Distal Renal Tubular Acidosis (dRTA) - Seite 2

Whether genetic or acquired as a consequence of an immune disease, dRTA affects an estimated 30,000 patients in Europe and approximately 20,000 in the United States.

About the Phase III European program in dRTA (B21CS pivotal study & B22CS extension study)
B21CS was a multicenter pivotal study that enrolled 37 patients suffering from dRTA, including adults, adolescents, children and infants and aimed to assess the efficacy of ADV7103 compared to Standard of Care (SoC) on blood and urine biomarkers of metabolic acidosis. Patients took the SoC treatment for five consecutive days followed by five days of two daily doses of ADV7103, an innovative prolonged-release granule combination of potassium citrate and potassium bicarbonate. Based on the blood and urine parameters, the study results demonstrated the effectiveness and suggested clinical benefit of ADV7103 in dRTA patients in comparison with the SoC.

The B22CS extension study was an open-label clinical study that confirmed the efficacy and safety of ADV7103 after 24 months of treatment. ADV7103 has successfully met the primary and secondary endpoints of the study and demonstrated its ability to treat biological disorders caused by dRTA.

About Advicenne
Advicenne (Euronext: ADVIC) is a pharmaceutical company founded by Dr. L.A. Granier and C. Roussel-Maupetit in 2007, specializing in the development of innovative treatments in Nephrology. Its lead drug candidate is currently in late-stage clinical trials for two kidney diseases: the renal tubular acidosis and cystinuria. ADV7103 has been granted orphan drug designation by the European Commission in the treatment of both conditions and has just received a positive CHMP opinion for the treatment of ATRd.

This is the second time Advicenne obtains a Marketing Authorization for an innovative pediatric product it has entirely developed: OZALIN a midazolam formulation for children for use in conscious sedation was registered in 2018 and is now commercialized in Europe by Primex.

Headquartered in Paris, Advicenne has been listed on the Euronext Paris stock exchange since 2017 and was cross-listed on the Euronext Brussels stock exchange in 2019.

For additional information: https://advicenne.com/