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CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

KING OF PRUSSIA, Pa., July 27, 2026 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced positive top-line Phase 3b results evaluating ANDEMBRY^® (garadacimab-gxii) in children aged 2 to 11 years with hereditary angioedema (HAE). ANDEMBRY is approved in over 40 countries for the prevention of HAE attacks in adult and pediatric patients aged 12 years and older.

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

CSL Reports Positive Top-Line Phase 3b Results Supporting Planned Expanded Pediatric Filing for ANDEMBRY® (garadacimab-gxii) in Children with Hereditary Angioedema (HAE)

Mon, 27 Jul 2026 09:00:00 -0400

CSL plans to begin submitting regulatory filings for expanded pediatric indication for ANDEMBRY in the first half of the company's fiscal year
Full data to be presented at upcoming scientific congress

EU panel recommends revoking Tavneos marketing authorization

Fri, 26 Jun 2026 09:02:00 -0400

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended revoking the European Union marketing authorization for TAVNEOS (avacopan), a treatment for adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis, the main forms of ANCA-associated vasculitis.

The recommendation, disclosed by Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL (ASX: CSL; USOTC: CSLLY), follows an Article 20 non-pharmacovigilance procedure initiated due to concerns related to data handling in the pivotal Phase 3 ADVOCATE trial, which supported the drug's original approval.

The CHMP opinion has been forwarded to the European Commission, which is expected to issue a

EU panel recommends revoking Tavneos marketing authorization

Fri, 26 Jun 2026 09:02:00 -0400

The CHMP opinion has been forwarded to the European Commission, which is expected to issue a

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

Fri, 26 Jun 2026 09:00:00 -0400

Recommendation follows an Article 20 non-pharmacovigilance procedure
Patients currently on TAVNEOS treatment should consult their treating physician

ST. GALLEN, Switzerland, June 26, 2026 /PRNewswire/ -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and CSL announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the revocation of the European Union (EU) marketing authorisation for TAVNEOS® (avacopan). TAVNEOS is a treatment for adults with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA), which are the main forms of ANCA-associated vasculitis. TAVNEOS

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

Fri, 26 Jun 2026 09:00:00 -0400

Recommendation follows an Article 20 non-pharmacovigilance procedure
Patients currently on TAVNEOS treatment should consult their treating physician

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

Fri, 26 Jun 2026 09:00:00 -0400

Recommendation follows an Article 20 non-pharmacovigilance procedure
Patients currently on TAVNEOS treatment should consult their treating physician

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

Fri, 26 Jun 2026 09:00:00 -0400

Recommendation follows an Article 20 non-pharmacovigilance procedure
Patients currently on TAVNEOS treatment should consult their treating physician

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

Fri, 26 Jun 2026 09:00:00 -0400

Recommendation follows an Article 20 non-pharmacovigilance procedure
Patients currently on TAVNEOS treatment should consult their treating physician

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

Fri, 26 Jun 2026 09:00:00 -0400

Recommendation follows an Article 20 non-pharmacovigilance procedure
Patients currently on TAVNEOS treatment should consult their treating physician

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

Fri, 26 Jun 2026 09:00:00 -0400

Recommendation follows an Article 20 non-pharmacovigilance procedure
Patients currently on TAVNEOS treatment should consult their treating physician

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

Fri, 26 Jun 2026 09:00:00 -0400

Recommendation follows an Article 20 non-pharmacovigilance procedure
Patients currently on TAVNEOS treatment should consult their treating physician

CHMP recommends revoking marketing authorisation for TAVNEOS® (avacopan) in the European Union

Fri, 26 Jun 2026 09:00:00 -0400

Recommendation follows an Article 20 non-pharmacovigilance procedure
Patients currently on TAVNEOS treatment should consult their treating physician