1. RSV vaccine-ABRYSVO has been approved for preventing lower respiratory tract infections
U.S. FDA has approved Pfizer’s RSV vaccine - ABRYSVO for preventing lower respiratory tract disease (LRTD) in individuals 18 through 59 years. ABRYSVO is an unadjuvanted, bivalent vaccine that contains two recombinant stabilised RSV prefusion F antigens inducing an immune response to potentially block viral entry. Meanwhile, it is also the only RSV immunization approved for pregnant women at 32 to 36 weeks of gestation which can protect infants from birth up to 6 months of age. The FDA’s approval is based on the positive data from the Phase 3 clinical trial where 2.38% of RSV-associated acute respiratory illnesses were presented in the vaccine-received group compared to 6.30% in the placebo group.
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2213836
https://www.pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-rsv-vaccine-abrysvor-adults-aged-18
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-top-line-results-abrysvor-rsv
2. ItovebiTM (inavolisib) combined with Palbociclib and fulvestrant can lengthen life spans of patients with late-stage breast cancer
Roche recently published an analysis of Phase III results evaluating ItovebiTM (inavolisib) in combination with Palbociclib and fulvestrant for treating breast cancer. Earlier last month, the new regime was approved for the treatment of adults with endocrine resistant, PIK3CA-mutated, hormone receptor positive, HER2 negative, locally advanced or metastatic breast cancer. The clinical trial results showed that the Itovebi-regimen group presents a progression free survival of 15.0 months compared to 7.3 months in either palbociclib or fulvestrant alone arm. Thus, the new regime presented more than doubling of the effects in reducing risk of disease worsening or death.
Source: https://www.roche.com/media/releases/med-cor-2024-10-31
3. Fabhalta® (iptacopan) may alleviate C3 glomerulopathy (C3G)
Novartis recently presented 12-month Phase III APPEAR-C3G study data showing that oral Fabhalta® (iptacopan) can maintain C3 glomerulopathy (C3G) patients well. The study involved a 6-month randomized, double-blind treatment period with Fabhalta compared to the placebo arm, followed by an additional 6-month open-label treatment period where all participants received Fabhalta. Data showed that Fabhalta resulted in clinically meaningful proteinuria reduction, which was seen as early as 14 days, and sustained at 12 months. Similarly, in the later 6 months, proteinuria reduction was seen in participants who were switched to Fabhalta. The indication has been approved by most international authorities, but still waiting for FDA approval.
4. Scemblix (asciminib) may correct molecular abnormalities in Ph+ leukemia
FDA granted accelerated approval to Novartis’ Scemblix (asciminib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (CML) in chronic phase. The approval was based on the positive results from the Phase III ASC4FIRST trial where Scemblix was compared to a range of selected tyrosine kinase inhibitors. There were 20% more patients reached major molecular response rate which refers to the reduction of the BCR-ABL fusion gene, which is a hallmark of CML compared to the standard of care therapy.
Source: https://www.novartis.com/news/media-releases/novartis-scemblix-fda-approved-newly-diagnosed-cml-offering-superior-efficacy-and-favorable-safety-and-tolerability-profile
5. TREMFYA® (guselkumab) has induced clinical remission of Crohn’s disease
Johnson & Johnson released Phase 3 GRAVITI results which evaluate subcutaneous induction of TREMFYA® (guselkumab) for Crohn’s disease treatment and maintenance. In week 12, more than half of the patients in the treatment group achieved clinical remission compared to the placebo group. Moreover, in week 48 both of the maintenance dose groups with 100 mg or 200 mg subcutaneous injection every eight weeks reached 60% and 66% clinical remission respectively, while there was only 17% in the placebo group. These results showed that TREMFYA has the potential to become the only IL-23 inhibitor to offer both SC and IV induction options for Crohn’s disease. The drug was previously approved by FDA to treat ulcerative colitis, however, an application for the treatment of Crohn’s disease is still under review.
6. DARZALEX® (daratumumab) is a new aiding medicine for treating multiple myeloma
Johnson & Johnson announced that the European Commission approved DARZALEX® (daratumumab, a CD38 directed antibody) subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd) to treat patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). This approval is supported by data from the Phase 3 PERSEUS study, where the regime reduced the risk of disease progression or death by 58% compared to VRd alone. The safety profile is aligned with the mono-therapy.
Source: https://www.jnj.com/media-center/press-releases/darzalex-daratumumab-sc-based-quadruplet-regimen-approved-by-the-european-commission-for-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-eligible
7. Mirikizumab has a long-term remission on ulcerative colitis and Crohn disease
Eli Lilly and Company showed results from two, multi-year, Phase 3 studies where patients treated with mirikizumab sustained stable, long-term remission across two types of inflammatory bowel diseases (IBD), ulcerative colitis (UC) and Crohn's disease. Mirikizumab selectively binds to the p19 subunit of IL-23 inhibiting its interaction with the IL-23 receptor. In LUCENT-3, 81% of patients with moderately to severely active UC maintained long-term clinical remission. While in VIVID-2 long-term study, 96% of patients showed measurable clinical response and 87% presented clinical remission.
Source: https://investor.lilly.com/news-releases/news-release-details/lillys-mirikizumab-first-and-only-il23p19-antagonist-report-long
8. Semaglutide has shown improvement of liver steatosis and fibrosis
Novo Nordisk announced part 1 results from an ongoing phase 3 trial which is a 240-week, double-blinded trial involving 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stage 2 or 3). Part 1 of the trial evaluated the effect of once-weekly semaglutide 2.4 mg on liver compared to the placebo arm on top of standard of care. At week 72, 37.0% of people treated with semaglutide achieved liver fibrosis improvement with no worsening of steatohepatitis compared to 22.5% of those on placebo. While 62.9% receiving semaglutide achieved steatohepatitis resolution with no worsening of liver fibrosis compared to 34.1% on placebo. Based on the clinical outcomes, the company aims to file and submit for regulatory approvals in the US and EU in the first half of 2025.
Source: https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=171971
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