ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche has reintroduced Susvimo, an ocular implant for neovascular age-related macular degeneration (nAMD), in the US. The FDA approved updates to Susvimo's implant and refill needle, which address previous performance issues that led to a voluntary recall in 2022. Susvimo offers a twice-yearly refill alternative to regular eye injections, continuously delivering medicine to the eye. This innovative approach, highlighted in Phase III studies, aims to maintain vision for patients with nAMD, a condition affecting 20 million people globally. The product will be available to US retina specialists and patients in the coming weeks.

Genentech, a member of the Roche Group, has announced the reintroduction of Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant to treat wet age-related macular degeneration (AMD) in the U.S. This comes after a voluntary recall in 2022.

The FDA has approved updates to Susvimo's ocular implant and refill needle, ensuring they meet performance standards. Susvimo offers a unique alternative to regular eye injections by providing continuous medication delivery through a refillable implant, requiring only two refills a year. This innovative approach could benefit 1.5 million people in the U.S. and 20 million globally who are affected by wet AMD.

The implant is surgically inserted and refilled every six months, providing sustained vision maintenance. Genentech is committed to easing access barriers and offers comprehensive support services for patients prescribed Susvimo.

On July 5, 2024, Roche announced that the FDA has approved its Vabysmo (faricimab) 6.0 mg prefilled syringe (PFS) for the treatment of neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). These conditions affect nearly 80 million people globally. The Vabysmo PFS is designed to simplify administration, offering a ready-to-use solution for retina specialists. This approval follows Vabysmo's initial US approval in 2022 and its availability in over 95 countries. More than four million doses have been distributed globally.

The FDA has approved Genentech's Vabysmo prefilled syringe (PFS) for treating three major causes of vision loss: wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Vabysmo PFS is the first syringe prefilled with an FDA-approved bispecific antibody aimed at retinal conditions, simplifying administration for retina specialists. This new format delivers the same 6.0 mg dose as the existing Vabysmo vials and will be available in the U.S. in the coming months. Vabysmo has shown significant improvements in vision and retinal drying and is already approved in over 95 countries.

Genentech, part of the Roche Group (OTCQX: RHHBY), announced that the Phase II/III SKYSCRAPER-06 study for metastatic non-squamous non-small cell lung cancer (nSq NSCLC) did not meet its primary endpoints. The study evaluated tiragolumab combined with Tecentriq and chemotherapy against pembrolizumab and chemotherapy. It failed the primary analysis for progression-free survival (PFS) with a hazard ratio (HR) of 1.27 and the first interim analysis for overall survival (OS) with a HR of 1.33. Reduced efficacy was observed in both PFS and OS compared to the comparator arm. The safety profile remained consistent with previous studies, but due to reduced efficacy, the trial will be halted. Results will be communicated to health authorities and presented at a future medical meeting. Ongoing Phase III studies will be re-evaluated based on these results.

Roche announced that the phase II/III SKYSCRAPER-06 study evaluating tiragolumab plus Tecentriq and chemotherapy against pembrolizumab and chemotherapy for untreated, metastatic non-squamous NSCLC did not meet the primary endpoints. The primary analysis showed a progression-free survival (PFS) hazard ratio (HR) of 1.27, and the first interim analysis indicated an overall survival (OS) HR of 1.33. Efficacy in both PFS and OS was inferior compared to the comparator arm. The trial will be halted due to reduced efficacy. Safety profiles remained consistent with previous studies. Results will be communicated to investigators and health authorities, and presented at a medical meeting.

Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for the extension of Vabysmo's marketing authorization. This extension includes the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). A final decision is expected soon from the European Commission.

The recommendation is based on data from two Phase III studies, BALATON and COMINO, involving over 1,200 patients. These studies showed that Vabysmo provided early and sustained vision improvements non-inferior to aflibercept, along with robust retinal drying.

If approved, Vabysmo will be the first bispecific antibody treatment for nearly one million people with RVO in the EU. Vabysmo is already approved in the US, Japan, and in over 95 countries for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Roche's PiaSky (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). PiaSky, a subcutaneous (SC) treatment administered monthly, offers an alternative to existing intravenous (IV) C5 inhibitors. The recommendation is based on results from the COMMODORE 2 study, which demonstrated that monthly SC PiaSky provides equivalent disease control and comparable safety to bi-weekly IV eculizumab. If approved by the European Commission, PiaSky will be the first monthly SC treatment for PNH in the EU, offering the option for patients to self-administer the treatment, potentially reducing the treatment burden and improving their quality of life.

The World Health Organization (WHO) has granted prequalification designations for Roche's cobas HPV test on the cobas 5800 System and for self-collected samples on the cobas 5800, 6800, and 8800 Systems.

This follows the U.S. FDA's recent approval of Roche’s HPV self-collection solution and a previous WHO prequalification for the cobas HPV test on the cobas 6800/8800 Systems.

Prequalification allows low- and middle-income countries (LMICs) to integrate these screening tools into national cervical cancer elimination programs, aiming to increase access and reduce cervical cancer incidences. This initiative is significant given that over 600,000 women are diagnosed with cervical cancer annually, leading to over 340,000 deaths. Notably, 90% of these deaths occur in LMICs.

Roche partners with over 55 countries, including Peru, to enhance HPV screening. Through these efforts, hundreds of thousands of women, particularly in underserved regions, have received important HPV testing.