" class="no-js "lang="en-US"> Calliditas’ Partner STADA Launches the First Medicine Authorized in the EU for Treating Primary IgA Nephropathy - Medtech Alert
Thursday, March 23, 2023

Calliditas’ Partner STADA Launches the First Medicine Authorized in the EU for Treating Primary IgA Nephropathy

Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that its European commercial partner, STADA Arzneimittel AG, has launched the first and only approved treatment in the EU for primary immunoglobulin A nephropathy (IgAN), a rare, progressive disease of the kidneys with a high unmet need. STADA will initially launch in Germany with additional European countries to follow.

“We are excited that STADA is in the position to swiftly launch this product in Europe, starting with the German market.  To bring an approved medication to patients suffering from this rare disease has been our focus since we started this endeavor well over a decade ago,” said Calliditas CEO Renée Aguiar-Lucander.

Calliditas received conditional approval in July from the European Commission for the development candidate Nefecon, providing the first and only approved treatment alternative for adult patients with IgAN at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. The conditional marketing authorization, which has now been transferred to STADA, applies in all 27 European Union Member States as well as Iceland, Norway, and Liechtenstein. This is the first orphan medicine introduced through STADA’s Specialty Care business unit.

“Making this product available to primary IgAN patients in Europe brings for the first time a therapeutic option to an under-served patient population,” commented STADA CEO Peter Goldschmidt. “The launch of STADA’s first orphan Specialty medicine is evidence of how STADA is bringing additional value to patients, healthcare professionals and health systems through a broad portfolio of Specialty, Generics and Consumer Healthcare products.“

People In This Post

Companies In This Post

  1. Bayer Expands Global Clinical Program for NUBEQA® (darolutamide) in Prostate Cancer Read more
  2. BIOTECanada Welcomes Government of Canada’s Strategy on Improving Access to Care for Patients with Rare Diseases Read more
  3. Marinus Pharmaceuticals Receives FDA Orphan Drug Designation for Ganaxolone in the Treatment of Lennox-Gastaut Syndrome Read more
  4. Aurion Biotech Receives Approval from Japan’s PMDA for New Drug Application Read more
  5. Morphimmune Appoints Dr. Clay Siegall Chief Executive Officer and President Read more