Amgen Submits Sotorasib Marketing Authorization Application To The European Medicines Agency
KRAS G12C Mutation
EU Application Follows Sotorasib New Drug Application Submission to U.S. FDA Announced Last Week
THOUSAND OAKS, California, Dec. 22, 2020 /PRNewswire/ Amgen (NASDAQ: AMGN) today announced submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for sotorasib, an investigational KRAS
G12C inhibitor, for the treatment of adult patients with previously treated
KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC). Just over two years since the first patient was dosed, sotorasib is now on track to potentially be the first approved targeted therapy for patients with previously treated NSCLC harboring the
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
ChemoCentryx and VFMCRP Provide Topline Results from ACCOLADE Trial of Avacopan in C3 .
ChemoCentryx, Inc.December 21, 2020 GMT
As in ANCA vasculitis, avacopan demonstrated statistically significant improvement in renal function as measured by eGFR compared to placebo over 26 weeks of blinded treatment
The change from baseline to Week 26 in C3 Glomerulopathy Histologic Index (C3G HI) for Disease Activity (primary endpoint) was not statistically different between the two treatment groups, while the C3G HI for Disease Chronicity (measuring progression of fibrosis) shows significant benefit for avacopan versus placebo
Amgen Submits Sotorasib Marketing Authorization Application To The European Medicines Agency | ANP Pers Support perssupport.nl - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from perssupport.nl Daily Mail and Mail on Sunday newspapers.
December 22, 2020 healthcare
VFMCRP and ChemoCentryx Provide Topline Results From ACCOLADE Trial of Avacopan in C3 Glomerulopathy Including Improved Estimated Glomerular Filtration Rate (eGFR)
Regulatory News:
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and ChemoCentryx, Inc. today announced topline data from the ACCOLADE clinical study, the largest, randomized, blinded, placebo-controlled phase-II trial in the ultra-rare kidney disease C3 glomerulopathy (C3G) to date, which evaluated avacopan for the treatment of that disorder. Avacopan is a first-in-class, orally-administered selective inhibitor of the complement C5a receptor.
Patients in the multi-center ACCOLADE clinical trial were randomized to receive either 30mg of avacopan twice daily (BID) or placebo for 26 weeks in a double-blind manner. The primary endpoint of the study was defined as the change from baseline in the C3G histologic index for disease activity, as determined by a blinded anal
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As in ANCA vasculitis, avacopan demonstrated statistically significant improvement in renal function as measured by eGFR compared to placebo over 26 weeks of blinded treatment
The change from baseline to Week 26 in C3 Glomerulopathy Histologic Index (C3G HI) for Disease Activity (primary endpoint) was not statistically different between the two treatment groups, while the C3G HI for Disease Chronicity (measuring progression of fibrosis) shows significant benefit for avacopan versus placebo
Avacopan safe and well tolerated in C3G patients
ChemoCentryx and VFMCRP plan to discuss registration pathway with regulatory agencies in US and EU
Conference call today at 4:30 pm Eastern Time