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.

Results of the first season of a randomized study showed adjuvanted and high-dose influenza vaccines did not differ in effectiveness against PCR-confirmed influenza.This is the first randomized study to evaluate the relative vaccine effectiveness of adjuvanted influenza vaccines compared to high-dose influenza vaccines for prevention of lab-confirmed influenza.

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 /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). 

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). 

CSL Seqirus has received a Biomedical Advanced Research and Development Authority (BARDA) award to complete the fill and finish process for additional pre-pandemic vaccines to further support the U.S. government's outbreak and preparedness response. BARDA has requested adjuvanted H5N1 pre-pandemic vaccines and additional H5N8 antigen as part of its decision to expand its portfolio of pre-pandemic vaccines.This $34 million investment is the sixth avian influenza pandemic preparedness award made to CSL Seqirus by BARDA. 

Results from real-world evidence (RWE) studies to be presented at OPTIONS XII show the effectiveness of cell-based and MF59® adjuvanted influenza vaccines.Results from different studies suggested improved relative vaccine effectiveness (rVE) of cell-based vaccines compared with egg-based vaccines in preventing test-confirmed influenza across different age groups, including children as young as six months.1,2Results from a real-world study covering the 2023/24 season showed that cell-based vaccine was effective against medically attended, laboratory-confirmed influenza, with vaccine effectiveness (VE) highest in children six months to three years of age at 88%, compared with unvaccinated participants.3RWE studies can play a key role in assessing influenza vaccine effectiveness each season. RWE complements randomized controlled trials (RCT), assessing influenza vaccine effectiveness on an ongoing basis and contributing to an ever-growing data set on real-world outcomes.

Head-to-head data, presented at OPTIONS XII for the Control of Influenza Conference, demonstrates advantage of sa-mRNA over conventional mRNA in duration of immune response; Results highlight CSL and Arcturus Therapeutics' commitment to advancing COVID-19 vaccine innovation to protect public health.

WALTHAM, Mass. and SAN DIEGO, Sept. 30, 2024 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and self-amplifying messenger RNA (sa-mRNA) pioneer Arcturus Therapeutics (Nasdaq: ARCT) today announced the results of a head-to-head study demonstrating that self-amplifying (sa-mRNA) COVID-19 vaccine maintained superior immunogenicity compared to the conventional mRNA vaccine Comirnaty® for up to one year against Wuhan-Hu-1, Omicron BA.4-5 and certain other variants, and at one-sixth the dose of the comparator (5 μg vs 30 μg, respectively).