OTTAWA, Canada, Aug. 8, 2025 /CNW/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced that Health Canada has granted a marketing authorization for ANDEMBRY® (garadacimab) for routine prevention of attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. ANDEMBRY is a monoclonal antibody designed to target activated FXII (FXIIa), a plasma protein at the top of the HAE cascade that plays a key role in attacks of swelling in people with HAE. ANDEMBRY reinforces CSL's decades-long commitment to advancing innovation for the HAE community and is authorized with a prefilled pen for subcutaneous self-injection.

KING OF PRUSSIA, Pa., June 16, 2025 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the U.S. Food and Drug Administration (FDA) approved ANDEMBRY® (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. By targeting factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE, ANDEMBRY inhibits the top of the HAE cascade to prevent HAE attacks. ANDEMBRY, the only treatment to offer once-monthly dosing from the start for all patients, is a subcutaneous self-injection delivered in 15 seconds or less via an autoinjector with a citrate-free formula.

First non-immunosuppressive dual-action therapy recommended by NICE for eligible patients with IgA nephropathy, a leading cause of kidney failure 1-3

NICE's recommendation is based on clinically meaningful results from the phase-III PROTECT trial 4

ST. GALLEN, Switzerland, May 23, 2025 /PRNewswire/ -- CSL Vifor is pleased to announce that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.3 NICE has provided guidance to ensure that only patients responding to treatment continue.3 The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025.5

First non-immunosuppressive dual-action therapy recommended by NICE for eligible patients with IgA nephropathy, a leading cause of kidney failure 1-3

NICE's recommendation is based on clinically meaningful results from the phase-III PROTECT trial 4

ST. GALLEN, Switzerland, May 23, 2025 /PRNewswire/ -- CSL Vifor is pleased to announce that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.3 NICE has provided guidance to ensure that only patients responding to treatment continue.3 The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025.5

First non-immunosuppressive dual-action therapy recommended by NICE for eligible patients with IgA nephropathy, a leading cause of kidney failure 1-3

NICE's recommendation is based on clinically meaningful results from the phase-III PROTECT trial 4

ST. GALLEN, Switzerland, May 23, 2025 /PRNewswire/ -- CSL Vifor is pleased to announce that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.3 NICE has provided guidance to ensure that only patients responding to treatment continue.3 The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025.5

First non-immunosuppressive dual-action therapy recommended by NICE for eligible patients with IgA nephropathy, a leading cause of kidney failure 1-3

NICE's recommendation is based on clinically meaningful results from the phase-III PROTECT trial 4

ST. GALLEN, Switzerland, May 23, 2025 /CNW/ -- CSL Vifor is pleased to announce that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.3 NICE has provided guidance to ensure that only patients responding to treatment continue.3 The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025.5

First non-immunosuppressive dual-action therapy recommended by NICE for eligible patients with IgA nephropathy, a leading cause of kidney failure 1-3

NICE's recommendation is based on clinically meaningful results from the phase-III PROTECT trial 4

ST. GALLEN, Switzerland, May 23, 2025 /PRNewswire/ -- CSL Vifor is pleased to announce that the National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending that sparsentan can be used in the NHS in England as an option to treat primary IgA nephropathy in adults with a urine protein excretion of 1.0 g/day or more, or a urine protein-to-creatinine ratio of 0.75 g/g or more.3 NICE has provided guidance to ensure that only patients responding to treatment continue.3 The decision follows authorisation from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025.5

European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN)

Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025

EU approval is based on the complete data set from the phase-III PROTECT study

ST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN)

Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025

EU approval is based on the complete data set from the phase-III PROTECT study

ST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /CNW/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN)

Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025

EU approval is based on the complete data set from the phase-III PROTECT study

ST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN)

Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025

EU approval is based on the complete data set from the phase-III PROTECT study

ST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

European Commission converts conditional approval of FILSPARI (sparsentan) into standard marketing authorization for the treatment of IgA Nephropathy (IgAN)

Decision follows positive recommendation from Committee for Medicinal Products for Human Use (CHMP) from February 2025

EU approval is based on the complete data set from the phase-III PROTECT study

ST. GALLEN, Switzerland and SAN DIEGO, April 29, 2025 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) are pleased to announce that the European Commission has approved the conversion of the conditional marketing approval (CMA) into a standard marketing authorization (MA) for FILSPARI for the treatment of adults with primary IgA nephropathy with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). Standard MA is granted for all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.

TOKYO, Feb. 20, 2025 /PRNewswire/ -- CSL Behring K.K. (Headquarters: Minato-ku, Tokyo; President and Representative Director: Izumi Yoshida) today announced that it has received manufacturing and marketing approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for ANDEMBRY® (garadacimab) Subcutaneous (S.C.) Injection 200mg Pens. The product is approved for the prevention of acute attacks of hereditary angioedema (HAE) and is the first pre-filled pen presentation for once-monthly subcutaneous administration for long-term prophylaxis of HAE. The approval in Japan follows additional recent approvals received in Australia, the United Kingdom, and the European Union.

- KOSTAIVE represents a significant advancement in vaccine technology, demonstrating superior immunogenicity and antibody persistence for up to 12 months post-vaccination compared to conventional mRNA COVID-19 vaccines in clinical trials

WALTHAM, Mass. and SAN DIEGO, Feb. 14, 2025 /PRNewswire/ -- Global biotechnology leader CSL (ASX: CSL; USOTC: CSLLY) and sa-mRNA pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced that the European Commission has granted marketing authorization for KOSTAIVE ® (ARCT-154), a self-amplifying mRNA COVID-19 vaccine, for individuals 18 years and older. KOSTAIVE is the first sa-mRNA COVID-19 vaccine to receive approval from the European Commission (EC). KOSTAIVE is currently marketed in Japan against COVID-19.

If approved, garadacimab will be the first and only once-monthly treatment inhibiting factor XIIa to prevent attacks in HAE patients – a community CSL has been serving for more than 40 years

MARBURG, Germany, Dec. 13, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending granting a marketing authorization for garadacimab as a once-monthly prophylactic treatment for hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. Garadacimab is a monoclonal antibody that targets activated factor XII (factor XIIa), a plasma protein that plays a key role in attacks of swelling in people with HAE, thereby inhibiting the HAE cascade at the top to prevent HAE attacks. The final European Commission (EC) decision is expected in Q1 2025.

SUMMIT, N.J., Oct. 18, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced the first season (2023-2024 influenza season) results of the first pragmatic randomized study to evaluate the relative vaccine effectiveness (rVE) of adjuvanted inactivated influenza vaccine (aIIV) compared to high-dose inactivated influenza vaccine (HD-IIV) for prevention of lab-confirmed influenza. Results for the first season demonstrated that adjuvanted and high-dose influenza vaccines did not differ in effectiveness against Polymerase Chain Reaction (PCR)-confirmed influenza with a rVE of aIIV vs HD-IIV of 1.5% (95% confidence interval: -8.4 to 10.5) among adults 65 years of age and older. In addition, there was no difference in effectiveness between aIIV and HD-IIV for the prevention hospitalization or emergency department visits for PCR-confirmed influenza, and hospitalization for all-cause community-acquired pneumonia.

Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial

ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). 

Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial

ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). 

Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial

ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). 

Temporary marketing authorization is based on statistically significant and clinically meaningful results from the phase-III PROTECT trial

ST. GALLEN, Switzerland and SAN DIEGO, Oct. 17, 2024 /CNW/ -- CSL Vifor and Travere Therapeutics, Inc., (NASDAQ: TVTX) today announced that Swissmedic has granted temporary marketing authorization for FILSPARI for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g).