GSK plc American Depositary Shares (Each representing two Ordinary Shares) - GSK STOCK NEWS

ViiV Healthcare, majority-owned by GSK and partnered with Pfizer, has received approval from the European Commission to update product guidelines for Vocabria and Rekambys. This allows HIV patients the option to start treatment directly with injections, bypassing the oral lead-in phase. The change aims to simplify the treatment initiation process, as both methods have shown similar efficacy and safety. This decision is based on positive phase III clinical trial results that support the new regimen.

ViiV Healthcare announced positive interim results from the CARISEL study evaluating a long-acting HIV treatment regimen of Vocabria (cabotegravir) and Rekambys (rilpivirine). Conducted during the COVID-19 pandemic, the study showed 97% of participants found the bi-monthly injection visits acceptable. Healthcare teams across five European countries largely agreed on the regimen's feasibility, with mean scores of 4.6 for acceptability. Additionally, implementation concerns among healthcare teams decreased significantly over time, indicating strong potential for this innovative treatment in diverse settings.

GSK Consumer Healthcare's Theraflu brand launched the Rest & Recover Fund to address barriers to sick time access and cultural stigma. A survey, the 2021 Temperature Check Report, showed that nearly 70% of working Americans have gone to work sick due to financial constraints. The fund, in partnership with Good+Foundation, aims to distribute microgrants to assist with lost wages from unpaid sick days, particularly benefiting Black and Latina mothers. Findings reveal that 58% of Americans avoid sick days for fear of reprimand, highlighting significant disparities in sick leave access and social pressures.

ViiV Healthcare launched a report in collaboration with Economist Impact, outlining actions to eliminate health disparities related to HIV, STIs, mental health, and COVID-19 in the US and UK over the next 20 years. The study highlights that current healthcare inequities are both avoidable and costly, urging stakeholders to adopt a cohesive approach towards health equity. Key recommendations include restructuring healthcare systems for prevention, reimagining investments, enhancing collaboration, and better targeting of interventions aimed at vulnerable populations.

ViiV Healthcare presented three-year findings from the Phase III TANGO study, demonstrating that the 2-drug regimen Dovato (dolutegravir/lamivudine) is non-inferior to the three-drug TAF-based regimens for HIV-1 patients. No virologic failures occurred in the Dovato group (0% vs <1% with TAF), reinforcing its viability as a treatment option. Notably, patients on Dovato displayed better management of fasting lipids. Overall adverse event rates were similar, with Dovato showing marginally higher drug-related AEs. This study was crucial in establishing Dovato's long-term effectiveness.

GSK Consumer Healthcare has launched Sensodyne Repair and Protect with Deep Repair, just in time for National Coffee Day on September 29, 2021. This new toothpaste is specially formulated for individuals with tooth sensitivity, allowing them to enjoy their favorite hot beverages without discomfort. According to a survey, 43% of people prefer hot coffee. Sensodyne's new product offers clinically significant sensitivity relief and additional benefits including cavity protection and whitening. The product is available at major retailers and online.

ViiV Healthcare announced that the FDA has accepted and granted Priority Review for its New Drug Application (NDA) for cabotegravir long-acting, intended for HIV pre-exposure prophylaxis (PrEP). If approved by the target date of 24 January 2022, cabotegravir will be the first long-acting therapy for preventing HIV infection. The NDA is supported by positive results from studies HPTN 083 and HPTN 084, which demonstrated cabotegravir's superiority over daily oral medications. ViiV will also submit to other regulatory authorities by the end of 2021.

ViiV Healthcare has announced a collaboration with Shionogi for S-365598, a third-generation HIV treatment aimed at ultra long-acting regimens. The agreement includes an upfront payment of £20 million and additional milestone payments totaling £15 million, alongside royalties on sales. Preliminary data suggest S-365598 could offer a distinct resistance profile and longer dosing intervals, enhancing patient adherence. Clinical studies are expected to start by 2023. This partnership aims to strengthen ViiV's pipeline for innovative therapies beyond 2030.

GlaxoSmithKline (GSK) has received FDA approval for Nucala (mepolizumab) as an add-on treatment for chronic rhinosinusitis with nasal polyps (CRSwNP) in adults over 18. This biologic is now the first anti-IL-5 option available for this condition, which affects over 5 million people in the US. The approval is based on the SYNAPSE study, which showed a 57% reduction in surgery rates for patients treated with mepolizumab versus placebo. The drug is already approved for other eosinophilic diseases, reinforcing GSK's commitment to managing eosinophilic inflammation.