Global Regulatory & Consumer Insights

Eli Lilly and Company Zepbound has become the first drug to be FDA-approved for obstructive sleep apnoea (#OSA), a sleep-related breathing disorder that is most common in people who are overweight and affects millions of people in the US. https://lnkd.in/gHT94nFT #sleepapnoea #Regulatorywriting #Regulatoryfiling

Ionis Pharmaceuticals, Inc. #olezarsen has become the first FDA-approved drug therapy for adults with familial chylomicronaemia syndrome (FCS), an ultra-rare disease that leads to elevated triglyceride levels in the blood. https://lnkd.in/gvbaQjc7. #RegulatoryAffairs raredisease #RegulatoryIntelligence

GSK says antibody drug succeeds in testing for chronic nasal condition: Called depemokimab, the company’s treatment reduced the size of nasal polyps in two Phase 3 trials of people with chronic rinosinusitis. Drugmaker GSK shared positive results Monday from two Phase 3 trials testing its inflammatory disease drug depemokimab in people with a condition known as chronic rhinosinusitis with nasal polyps. Earlier this year, the company said the same drug was successful in late-stage testing of adults and teenagers with asthma. Data from trials in both indications will be used for regulatory approval applications. GSK is also studying depemokimab in two other inflammatory diseases. GSK has set high expectations for the drug, predicting that, if approved, it could bring in over 3 billion pounds in peak annual sales. https://lnkd.in/dTtBhrrj

Otsuka’s startup bet pays off with kidney disease drug results A medicine the pharma acquired in a $430 million buyout of Visterra in 2018 succeeded in a Phase 3 trial in IgA nephropathy, a crowded corner of drug research. The drug, called sibeprenlimab, met its main goal in a study in IgA nephropathy, or IgAN, a chronic condition that can lead to kidney failure. Upon a pre-specified, interim analysis after nine months of treatment, the company said sibeprenlimab therapy was associated with a “statistically significant and clinically meaningful” reduction, versus placebo, in the amount of protein in participants’ urine — a marker of kidney health. https://lnkd.in/grm3NCbh #RegulatoryAffairs #RegulatoryChanges #Regulatoryconsulting

Global Regulatory & Consumer Insights wishes a VERY HAPPY DIWALI

Sobi - Swedish Orphan Biovitrum AB (publ) gets EU okay for long-acting haemophilia A drug: The European Commission has approved Sobi’s long-acting factor VIII replacement therapy #Altuvoct for the treatment of #haemophilia A in the #EU, with a broad label that spans all ages and any disease severity. Altuvoct (efanesoctocog alfa) is dosed by injection once a week and is a successor to Sobi’s long-established haemophilia A therapy Eloctate (efmoroctocog alfa) – sold by partner Sanofi – which has to be dosed every four days and sometimes even more frequently. The new drug was also developed in partnership with Sanofi and was approved in the US last year as Altuviio. https://lnkd.in/eQAB_hG6

Regeneron touts success with bispecific antibody in multiple myeloma trial  Regeneron has released encouraging trial results for its multiple myeloma antibody, #linvoseltamab. The data from the Phase I/II LINKER-MM1 (NCT03761108) study was presented at the European Hematology Association (EHA) Congress 2024 in Madrid, Spain, on 13–16 June.  The 14-month follow up data demonstrated a 71% objective response rate, with 50% of patients achieving a complete response or better and 63% achieving a very good partial response or better, as determined by an independent review committee.  The median overall survival (OS) was 31 months, while the median progression free survival (PFS) and median duration of response (DoR) were not reached, as patients had not progressed yet. The median DoR for all responders was 29 months. https://lnkd.in/gsz5frwg

APAC leaps ahead in adoptive cell therapy space: There are approximately twelve times more single-country adoptive cell therapy clinical trials being run in the APAC region than in Europe. At the Annual Outsourcing in Clinical Trials conference, held from 11-12 June, Chung-Siu led a comprehensive session on adoptive cell therapies, giving an overview of the space to the audience of clinical trial professionals. Chung Siu cited a GlobalData report that demonstrated that the number of ongoing single-country adoptive cell therapy studies in the APAC region has reached approximately twelve times the number of trials in Europe. He also highlighted that overall, there are 1,023 single country adoptive cell therapy clinical studies being run in the APAC region compared to 476 in North America. https://lnkd.in/gww3bRjQ