ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Genentech announced FDA approval for Actemra® (tocilizumab) subcutaneous injection to slow pulmonary function decline in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD). This marks the first biologic therapy approved for this condition, impacting approximately 75,000 patients in the U.S. Key findings from the focuSSced Phase III trial indicated that Actemra reduced lung function decline compared to placebo, although the primary endpoint related to skin fibrosis was not met.

Common side effects included infections, aligning with Actemra's known safety profile.

Roche has received special approval from the German Federal Institute for Drugs and Medical Devices (BfArM) for its SARS-CoV-2 Rapid Antigen Test, allowing home self-testing using a nasal swab. This test simplifies the sampling process and provides results in just 15 minutes. It will be available without prescription in pharmacies across Germany. The test demonstrated a sensitivity of 82.5% and 100% specificity compared to RT-PCR. Roche's ongoing commitment to combat COVID-19 is evident through this new offering, expanding its diagnostic portfolio and supporting healthcare systems.

Roche (RHHBY) announced that the European Medicines Agency’s CHMP supports its investigational COVID-19 antibody cocktail, casirivimab and imdevimab. This scientific opinion enables EU member states to use the treatment before formal authorization during public health emergencies. Roche, in collaboration with Regeneron, aims to distribute over 2 million doses in 2021, targeting high-risk COVID-19 patients. The cocktail is currently assessed in multiple clinical trials, with approximately 23,000 participants involved.

Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of Evrysdi for treating spinal muscular atrophy (SMA) in patients aged two months and older. This recommendation is based on positive outcomes from pivotal trials: FIREFISH and SUNFISH, showcasing significant motor function improvements. With over 2,500 patients treated, Evrysdi aims to fill the therapeutic gap in SMA care. The final approval decision is expected from the European Commission in two months, affecting all EU member states and select countries.

Roche announced that data from the FIREFISH Part 1 study published in the New England Journal of Medicine shows that after 12 months of treatment with Evrysdi, 90% of infants survived without permanent ventilation. Additionally, 33% of infants could sit unsupported for at least 5 seconds, a significant motor milestone. Evrysdi, FDA-approved in August 2020 as the first oral treatment for SMA, has shown a median increase of 1.9-fold in SMN protein levels. Despite some serious adverse events, no fatalities were attributed to Evrysdi.

Genentech, part of the Roche Group, announced publication of Evrysdi™ (risdiplam) data from the pivotal FIREFISH study. The study showed that 90% of infants with symptomatic Type 1 spinal muscular atrophy (SMA) survived without permanent ventilation after 12 months of treatment. Additionally, 33% of infants could sit independently for at least 5 seconds. The data highlights the drug's effectiveness in increasing survival of motor neuron (SMN) protein levels. Evrysdi, FDA-approved in August 2020, has promising implications for treating SMA in infants.

Genentech has announced positive results from four Phase III studies on its investigational bispecific antibody, faricimab, targeting diabetic macular edema (DME) and wet age-related macular degeneration (nAMD). Faricimab demonstrated non-inferior vision gains compared to aflibercept, with patients able to extend treatment intervals up to four months. Approximately 52.8% of DME patients and 45.7% of nAMD patients achieved four-month dosing in the first year. The studies showed no unexpected safety signals, indicating faricimab may improve treatment adherence and outcomes.

Roche announced positive results from four phase III studies of its investigational bispecific antibody, faricimab, for treating diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). Approximately 50% of patients could be treated every four months, with about 75% treated every three months or longer. Faricimab showed non-inferior vision gains compared to aflibercept and demonstrated consistent improvements in anatomical outcomes. If approved, it would be the first new treatment for nAMD in 15 years and for DME in nearly a decade.

Roche has received FDA 510K clearance for stabilised urine samples with its cobas® BKV Test, marking a significant advancement in managing BK virus (BKV) in transplant patients. This non-invasive test allows easier collection and storage of urine samples, enhancing diagnosis capabilities. The test is critical as BKV can cause severe complications in immunocompromised patients, often indicated by higher BKV DNA levels in urine. Roche aims to provide standardized solutions for monitoring infection risks, furthering its commitment to improving transplant patient care.