News round-up for 21-25 April by DDW Senior Digital Content Editor Diana Spencer. With Eli Lilly so far winning the race to bring an oral GLP-1 drug to market, having announced positive topline results from a Phase III trial, this week our news highlights focus on clinical studies. Read More
Eli Lilly has announced positive topline Phase III results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycaemic control with diet and exercise alone. Orforglipron is the first oral small molecule glucagon-like peptide-1 (GLP-1) receptor… Read More
Newly published Phase III trial results suggest the new antibiotic gepotidacin could treat uncomplicated urogenital gonorrhoea (GC). The trial showed that gepotidacin was non-inferior with 92.6% success rates when compared to 91.2% success rates for intramuscular ceftriaxone plus oral azithromycin combined therapy, a leading combination treatment… Read More
Researchers have reported a potential oral treatment for Alzheimer’s disease (AD) that slowed its progression over a period of at least 18 months. Developed by Singaporean company TauRx Pharmaceutics, the scientists based in Aberdeen, UK, report that hydromethylthionine mesylate (HMTM) could be the first oral treatment for… Read More
Biotechnology company Orca Bio has revealed positive results from the Phase III Precision-T study of Orca-T, its lead investigational allogeneic T-cell immunotherapy, in patients with haematological malignancies. The trial included patients with acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute… Read More
The Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Sarclisa, in combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM) based on data from the IMROZ Phase III study. Olivier Nataf, Global Head of… Read More
The Scottish Medicines Consortium (SMC) has accepted Libtayo (cemiplimab) for use on the National Health Service (NHS) as a second-line monotherapy for adults with recurrent or metastatic cervical cancer. It is approved in patients who have disease progression on or after platinum-based chemotherapy, irrespective of PD-L1 expression… Read More
Eli Lilly’s Zepbound/Mounjaro (tirzepatide) provided a 47% greater relative weight loss compared to Wegovy (semaglutide, also known as Ozempic), according to topline results from the SURMOUNT-5 Phase IIIb clinical trial. On average, Zepbound led to a superior weight loss of 20.2% compared to 13.7% with Wegovy. … Read More
The US Food and Drug Administration (FDA) has approved BridgeBio Pharma’s Attruby (acoramidis), a near-complete (≥90%) stabiliser of Transthyretin (TTR). It is approved for the treatment of adults with Transthyretin amyloid cardiomyopathy (ATTR-CM) to reduce cardiovascular death and cardiovascular-related hospitalisation. The FDA approval is based… Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Balversa (erdafitinib) as a monotherapy for the treatment of adults with unresectable or metastatic urothelial carcinoma (UC). Specifically, the indication covers patients harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations,… Read More
The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year old. The approval is limited to children aged one to 11 years who weigh at least 15kg and who are inadequately controlled by, intolerant to, or… Read More
AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be… Read More
The European Commission has conditionally approved Iqirvo (elafibranor) 80mg tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA). The approval is limited to adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Read More
New data from the Phase III BouNDless trial and its ongoing open-label extension (OLE) support the long-term efficacy of ND0612 in people with Parkinson’s disease (PD) experiencing motor fluctuations. The new clinical trial data was shared at the 2024 International Congress of Parkinson’s Disease and Movement… Read More
Nxera Pharma Japan has received approval from the Ministry of Health, Labour and Welfare of Japan (MHLW) of its New Drug Application (NDA) for ACT-541468 (daridorexant or Quviviq) in 25 and 50mg doses for the treatment of adult patients with insomnia. The approval of Quviviq, a… Read More
A new multinational clinical trial will investigate whether a novel treatment can help slow the progression of chronic kidney disease (CKD). The EASi-KIDNEY trial will evaluate whether vicadrostat, also known as BI 690517, improves clinical outcomes when it is given in combination with existing treatments. Read More
