STOCKHOLM, May 15, 2024 /PRNewswire/ --
("Calliditas"), today announced upcoming data presentations and a sponsored symposium at the 61st European Renal Association (ERA) Congress, in Stockholm, Sweden on May 23 - 26, 2024.
"We are delighted to participate in ERA and look forward to engaging with the leaders in the renal space," said Richard Philipson, Chief Medical Officer at Calliditas. "We are especially excited to be in Stockholm, where Calliditas is headquartered and where we developed the first treatment specifically designed for IgA nephropathy, to present analyses that highlight the continued opportunity for our treatment to address the significant unmet need in this rare disease." The presentation and symposium details are below. Following the meeting, they will be available on the Presentations and Publications page on Calliditas' corporate website. Oral Poster Presentation: 501129
Date and Time: May 25 3:15-4:30 CET
Location: Focused Oral Room 3
Title: "Real-world challenges associated with the use of systemic glucocorticoids in a US IgAN cohort"
Date and Time: May 26 8:54-9:06 CET
Date and Time: Saturday, May 25: 10:15 - 11:15 am (Room A2+A3)
For more information, visit the ERA 2024 website here.
Important Safety Information
Hypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy or switching between corticosteroids, monitor for signs of adrenal axis suppression. Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B). Adverse reactions: In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO treated patients, and ≥2% higher than placebo) were peripheral edema (17%), hypertension (12%), muscle spasms (12%), acne (11%), headache (10%), upper respiratory tract infection (8%), face edema (8%), weight increased (7%), dyspepsia (7%), dermatitis (6%), arthralgia (6%), and white blood cell count increased (6%). Use in specific populations
Pregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in-utero corticosteroids, including budesonide, are at risk for hypoadrenalism. Full Prescribing Information
TARPEYO is an oral 4mg delayed release formulation of budesonide, designed to remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer's patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. For further information, please contact:
Åsa Hillsten, Head of IR & Sustainability, Calliditas
Tel.: +46 76 403 35 43, Email: [email protected]
The information was sent for publication, through the agency of the contact persons set out above, on May 15, 2024, at 14.00 p.m. CET.
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