GSK plc reports developments across its global biopharma business, including vaccines, respiratory medicines, infectious disease, immunology and oncology programs. Recurring updates include regulatory decisions and clinical evidence for products such as AREXVY, GSK's RSV vaccine, and Exdensur for severe asthma, along with data presentations, product indications and therapeutic-area access initiatives.
GSK news also covers manufacturing and supply agreements, commercial collaborations, public-health grant programs and product partnerships tied to its medicine and vaccine portfolio. As an American Depositary Share issuer, company updates may reflect both parent-company announcements and ADR-related market disclosures.
On November 17, 2021, GSK's Robitussin announced a partnership with All Stars Project, Inc. to enhance access to performing arts education for underserved youth. Committing $50,000, Robitussin aims to bridge educational inequities highlighted by the National Center for Education Statistics. Additionally, they will collaborate with Tony Award-winning actress Adrienne Warren to elevate young voices. On November 30, an Instagram Live event will further promote the initiative. The company also partnered with Good360 to donate cough care products to those in need, emphasizing its commitment to equitable health solutions.
GlaxoSmithKline (GSK) has announced a partnership with comedian Ronny Chieng for Thanksgiving, offering consumers holiday hacks through TUMS®, the leading heartburn relief brand. From November 23-25, Chieng will answer consumer queries on Twitter, addressing common holiday dilemmas like cooking mishaps. This initiative is part of TUMS®' ongoing efforts to ensure celebratory gatherings are enjoyable despite potential heartburn. TUMS® continues to be the most recommended adult antacid brand, providing quick relief for heartburn and related symptoms.
GlaxoSmithKline plc (GSK) announced positive Phase III results for daprodustat, an oral treatment for anaemia in chronic kidney disease (CKD), at the American Society of Nephrology's Kidney Week 2021. The ASCEND programme, involving over 8,000 patients, demonstrated daprodustat's efficacy and safety, achieving non-inferiority in cardiovascular risk compared to standard treatment. Primary efficacy endpoints were met in both ASCEND-ND and ASCEND-D studies, with improvements in haemoglobin levels. Daprodustat is currently approved in Japan and will support global regulatory filings.
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.