Biotechnology company Amgen (NASDAQ:AMGN) and biopharmaceutical UCB (Euronext Brussels:UCB) on Friday jointly reported the resubmission of the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for EVENITY for treating osteoporosis in postmenopausal women at high risk for fracture.
According to the company, EVENITY (romosozumab), which is an investigational monoclonal antibody, is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to rapidly increase bone formation and reduce bone resorption simultaneously
The company said the original US FDA submission included data from a comprehensive Phase 1 and Phase 2 programme and the Phase 3 placebo-controlled FRAME study, including 7,180 postmenopausal women with osteoporosis.
EVENITY's updated BLA includes results from two more recent pivotal Phase 3 trials: the ARCH study, an alendronate-active comparator trial including 4,093 postmenopausal women with osteoporosis who experienced a fracture as well as the BRIDGE study, including 245 men with osteoporosis. The US FDA will evaluate the clinical risk profile of EVENITY, the cardiovascular and safety signal seen in postmenopausal women with osteoporosis, disclosed the company.
In conjunction, the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Device Agency (PMDA) in Japan are currently reviewing marketing applications for EVENITY and interactions with the agencies are ongoing, concluded the company.
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML