Allergan has initiated two global clinical research programs for brazikumab, an investigational drug being studied for inflammatory bowel disease (IBD). Intrepid (Crohn’s disease) and Expedition (ulcerative colitis), will evaluate the safety and efficacy of brazikumab and will investigate the role of biomarkers in determining a predictive response of brazikumab in patients with IBD. They are the first…
Allergan Receives FDA Fast Track Designation For Major Depressive Disorder Treatment
Allergan plc announced the FDA has granted Fast Track designation for AGN-241751, an investigational new treatment for Major Depressive Disorder (MDD). AGN-241751 is a novel, oral, rapid-acting anti-depressant that recently entered Phase 2 development. “The FDA’s decision to grant Fast Track Designation for AGN-241751 corroborates our effort to develop new, highly innovative treatment options for patients…
Allergan And Richter Achieve Positive Topline Results From Trials Of Cariprazine
Allergan plc. and Gedeon Richter plc. announced positive topline results for RGH-MD-53, a Phase 3 study of cariprazine for the treatment of adults with major depressive episodes associated with bipolar I disorder (bipolar I depression). The companies announced in December 2017 positive topline results for the second pivotal trial (RGH-MD-54) of cariprazine in the treatment of bipolar…
FDA Extends Review Period For Allergan’s Ulipristal Acetate NDA
Allergan plc, a global pharmaceutical company, today announced that it was notified by the U.S. Food and Drug Administration (FDA) that the review of the New Drug Application (NDA) for ulipristal acetate will be extended. The PDUFA target action date has been extended to August 2018 to provide time for a full review of the file. Ulipristal acetate,…
Allergan Treatment Approved For Hospital-Acquired Bacterial Pneumonia
FDA approves Avycaz (ceftazidime and avibactam) for the treatment of patients with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The U.S. Food and Drug Administration (FDA) has approved Allergan plc’s supplemental New Drug Application (sNDA) to expand the approved use of Avycaz (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated…
