GSK and Novartis Complete $16 Billion Asset Swap Deal, Reshaping Both Companies' Strategic Focus
• GlaxoSmithKline and Novartis have completed their $16 billion asset swap deal, with GSK exchanging its oncology portfolio for Novartis's vaccines business, while also creating a joint consumer healthcare venture.
• Analysts question GSK's decision to exit oncology—a high-growth therapeutic area where its portfolio showed 32% growth in 2014—while Novartis is praised for strengthening its position in the lucrative cancer market.
• The strategic realignment allows both companies to focus on core strengths, with GSK concentrating on respiratory, HIV, vaccines and consumer healthcare, while Novartis enhances its prescription medicine portfolio with particular emphasis on oncology.
GSK's Linerixibat Shows Significant Improvement in Cholestatic Pruritus for Primary Biliary Cholangitis Patients
• GSK's phase III GLISTEN trial demonstrates linerixibat significantly improves cholestatic pruritus (relentless itch) in patients with primary biliary cholangitis, addressing a major quality of life concern.
• The late-breaking results were presented at the European Association for the Study of the Liver (EASL) Congress 2025, highlighting the potential for a new treatment option for this challenging symptom.
• Primary biliary cholangitis is a chronic autoimmune liver disease that primarily affects women, with pruritus being one of the most debilitating symptoms impacting daily functioning and quality of life.
FDA Approves Pre-Filled Syringe for Self-Injection of Efgartigimod in gMG and CIDP Patients
• The FDA has approved a new pre-filled syringe formulation of efgartigimod (VYVGART Hytrulo) for self-injection in adults with generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
• The self-injection option provides patients greater independence and flexibility, allowing treatment at home or while traveling, reducing the need for frequent clinic visits while maintaining the medication's established safety and efficacy profile.
• Developed through argenx's partnership with Halozyme's ENHANZE drug delivery technology, the pre-filled syringe enables rapid 20-30 second subcutaneous administration, with regulatory decisions expected in the EU, Japan, and Canada by 2025.
FDA Approves Blujepa, First New Class of Oral Antibiotic for UTIs in Nearly 30 Years
• GSK's Blujepa (gepotidacin) has received FDA approval for treating uncomplicated urinary tract infections, marking the first new class of oral antibiotics for UTIs in nearly three decades.
• The novel triazaacenaphthylene antibiotic demonstrated non-inferiority or superiority to nitrofurantoin in clinical trials, offering a new treatment option amid rising antibiotic resistance concerns.
• Blujepa works through a unique dual-enzyme inhibition mechanism that may reduce the potential for resistance development, with commercial availability expected in the second half of 2025.
ViiV Healthcare's Mid-Stage Study Demonstrates Robust HIV Viral Suppression with Long-Acting Therapy
• ViiV Healthcare, a joint venture between GSK and Pfizer, reported promising results from their Phase II trial showing strong viral suppression in HIV patients using their novel long-acting therapy.
• The investigational treatment demonstrated high efficacy rates with a convenient dosing schedule, potentially addressing adherence challenges associated with daily oral antiretroviral regimens.
• Researchers highlighted the therapy's favorable safety profile and potential to significantly improve quality of life for people living with HIV by reducing treatment burden.
ViiV Healthcare's N6LS Broadly Neutralizing Antibody Shows Promise in HIV Long-Acting Treatment
• Phase IIb EMBRACE study demonstrates N6LS (VH109), administered every four months with monthly cabotegravir, successfully maintained viral suppression in 96% of participants receiving intravenous treatment.
• The broadly neutralizing antibody was generally well-tolerated, with subcutaneous administration showing more infusion site reactions (14%) compared to intravenous delivery, which reported no such reactions.
• Based on favorable results, ViiV Healthcare is advancing development of a six-month IV formulation of N6LS combined with cabotegravir long-acting for evaluation in the next phase of the EMBRACE trial.
Lenacapavir and Broadly Neutralizing Antibodies Show Promise as Twice-Yearly HIV Treatment
• Phase II trial results demonstrate that lenacapavir combined with two broadly neutralizing antibodies (teropavimab and zinlirvimab) maintained viral suppression in 96% of participants over 26 weeks, comparable to daily oral regimens.
• The LTZ regimen (lenacapavir, teropavimab, zinlirvimab) could become the first complete twice-yearly HIV treatment option, potentially transforming care for people living with HIV by eliminating daily pill requirements.
• Pre-treatment screening for viral sensitivity to the antibodies is crucial, with approximately half of those screened showing high susceptibility to both antibodies, while others demonstrated sensitivity to at least one.
Integrase Inhibitor HIV Regimens Linked to Higher Cardiometabolic Risks, REPRIEVE Study Reveals
• ACTG researchers found that HIV patients switching to integrase inhibitor-based antiretroviral regimens faced increased risks of obesity, diabetes, hypertension, and metabolic syndrome over five years.
• The REPRIEVE study, presented at CROI 2025, analyzed 2,708 participants and found no elevated risk of major adverse cardiovascular events despite the metabolic changes.
• Experts recommend long-term monitoring for cardiometabolic complications in patients using integrase inhibitor-containing regimens, with 82% of study participants using dolutegravir-based treatments.
ViiV Healthcare Showcases Long-Acting HIV Innovations and Pipeline Advances at CROI 2025
• Real-world data presented at CROI 2025 demonstrates zero HIV acquisitions and high persistence with Apretude (cabotegravir LA) for PrEP across diverse populations, reinforcing its effectiveness in HIV prevention.
• Long-term follow-up data from multiple studies confirms the sustained efficacy and safety of Cabenuva (cabotegravir + rilpivirine LA) as a complete treatment regimen for people living with HIV.
• Late-breaking phase IIb data reveals promising results for an investigational broadly neutralizing antibody (VH3810109) in combination with cabotegravir LA, potentially expanding long-acting treatment options.
Gilead Sciences Resolves Major Patent Disputes with $1.25B Settlement to ViiV and Agreement with US Government
• Gilead Sciences has settled a significant patent dispute with ViiV Healthcare, agreeing to pay $1.25 billion plus ongoing royalties on Biktarvy sales until 2027, resolving litigation dating back to 2018.
• Separately, Gilead reached a settlement with the US government over patent infringement allegations related to HIV prevention drugs Truvada and Descovy, following Gilead's victory in a 2023 jury trial.
• Despite these legal resolutions, Gilead reported a 2% decline in fourth quarter sales, primarily due to decreased demand for COVID-19 therapy Veklury, while HIV treatment Biktarvy remained strong with 22% growth.
Quebec Leads Canada in HIV Prevention: First to Cover Long-Acting Injectable PrEP APRETUDE
• Quebec becomes the first Canadian province to provide public reimbursement for APRETUDE, a long-acting injectable HIV prevention drug, through RAMQ coverage for at-risk individuals.
• Real-world studies demonstrate over 99% effectiveness of APRETUDE for HIV prevention in nearly 1,300 individuals, showing superior efficacy compared to daily oral alternatives.
• The decision comes as HIV cases in Quebec have surged 37% between 2019 and 2022, marking a significant step forward in addressing the rising infection rates.
Patent Dispute Emerges Between Merck and Halozyme Over Injectable Keytruda Formulation
• Halozyme Therapeutics and Merck are heading into a patent battle over the development of an injectable formulation of the blockbuster cancer drug Keytruda.
• The dispute centers around Halozyme's drug delivery technology, which could potentially transform Keytruda's administration from intravenous to subcutaneous injection.
• This legal confrontation highlights the growing importance of drug delivery innovations in the pharmaceutical industry, particularly for established cancer therapeutics.
DARZALEX® Subcutaneous Regimen Receives CHMP Backing for Newly Diagnosed Multiple Myeloma Treatment
• Johnson & Johnson's DARZALEX® subcutaneous formulation combined with VRd receives positive CHMP recommendation for treating newly diagnosed multiple myeloma patients, regardless of transplant eligibility.
• The recommendation is supported by the Phase 3 CEPHEUS study, which evaluated the efficacy of daratumumab-VRd compared to VRd alone in 395 patients with newly diagnosed multiple myeloma.
• DARZALEX® has demonstrated significant impact in multiple myeloma treatment, having been used in over 618,000 patients worldwide and currently approved in eight indications.
GSK's Portfolio Resilience: Cancer and HIV Gains Offset RSV Vaccine Decline
• GSK experienced a significant 51% decline in Arexvy RSV vaccine sales to £590 million in 2024, following restricted US recommendations limiting use to adults 75 and older.
• Strong performance in oncology with 72% sales growth to £408 million, driven by Jemperli and Ojjaara, while HIV portfolio showed double-digit growth through Cabenuva, Apretude, and Dovato.
• Despite vaccine challenges, GSK upgraded its long-term sales forecast to £40 billion by 2031, supported by pipeline progress and planned launches in respiratory, oncology, and infectious diseases.
Global HIV/AIDS Crisis: Latest Statistics Show 40 Million Living with HIV as Prevention and Treatment Options Expand
• Recent global data reveals approximately 40 million people are currently living with HIV worldwide, with 1.2 million cases in the United States among individuals over 13 years old.
• Advanced treatment options including integrase inhibitor-based regimens like Biktarvy have shown high efficacy, with PrEP medications demonstrating up to 99% effectiveness in preventing HIV transmission through sexual contact.
• Pharmacists are gaining expanded roles in HIV care, with several states now allowing them to prescribe PrEP and PEP medications, improving accessibility to preventive treatments.
FDA Approves Subcutaneous Opdivo Qvantig for Multiple Solid Tumors
• The FDA has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) for subcutaneous use, offering a new administration option for various solid tumors.
• The approval was based on the CheckMate-67T trial, demonstrating non-inferior pharmacokinetic exposures and comparable safety to intravenous Opdivo.
• Opdivo Qvantig provides a faster administration time of 3-5 minutes compared to the 30-minute intravenous infusion, enhancing patient convenience.
• This subcutaneous formulation is approved for most previously approved adult solid tumor Opdivo indications, either as monotherapy or in combination with other treatments.
VYVDURA Approved in Japan for Chronic Inflammatory Demyelinating Polyneuropathy
• Japan's MHLW has approved VYVDURA (efgartigimod alfa and hyaluronidase-qvfc) for treating adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
• VYVDURA is the first and only neonatal Fc receptor (FcRn) blocker approved for CIDP treatment, administered as a weekly subcutaneous injection.
• The approval is based on the ADHERE study, which demonstrated a 61% reduction in relapse risk compared to placebo (p<0.0001) and clinical improvement in 69% of patients.
• This approval expands treatment options for CIDP patients in Japan, offering a convenient at-home self-injection alternative.
European Commission Approves Vocabria + Rekambys for HIV Treatment in Adolescents
• The European Commission has authorized Vocabria in combination with Rekambys for treating HIV-1 in adolescents aged 12 and older who are virologically suppressed.
• This long-acting injectable regimen reduces the treatment burden from 365 daily pills to as few as six injections per year.
• Clinical trials, including the MOCHA study, showed high rates of virologic suppression and a strong preference for the injectable regimen among adolescents.
• The approval marks a significant step in providing more convenient and less stigmatizing treatment options for young people living with HIV.
CHMP Recommends Opdivo Plus Yervoy for First-Line Treatment of Advanced Liver and Colorectal Cancers
• The CHMP has recommended Opdivo plus Yervoy for first-line treatment of unresectable or advanced hepatocellular carcinoma (HCC) based on the CheckMate -9DW trial.
• CheckMate -8HW trial results showed a 79% reduction in disease progression or death risk compared to chemotherapy for microsatellite instability-high/mismatch repair deficient colorectal cancer.
• The European Commission will review the CHMP's recommendation, potentially expanding treatment options for these cancers in the European Union.
• Opdivo plus Yervoy has shown statistically significant improvements in overall survival and objective response rate compared to existing therapies.
CHMP Recommends Subcutaneous Amivantamab for EGFR-Mutated NSCLC Treatment
• The CHMP has recommended subcutaneous amivantamab with lazertinib for first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations.
• Subcutaneous amivantamab monotherapy is recommended for NSCLC with EGFR exon 20 insertion mutations after platinum-based therapy failure.
• PALOMA-3 study results support the recommendation, showing non-inferior pharmacokinetics and a five-fold reduction in infusion-related reactions compared to IV administration.
• The subcutaneous formulation reduces administration time to approximately five minutes, offering improved convenience and safety for patients.
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