Drugs in the Pipeline

Drugs in the Pipeline

BLA for Novel Cholesterol Drug Submitted to FDA

Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for evolocumab for the treatment of high cholesterol.

FDA Fast Tracks Clostridium Difficile Vaccine

The Food and Drug Administration (FDA) has granted Fast Track status for Pfizer's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090).

First Treatment for Common Anemia Shows Promise

A recent study has demonstrated potential for lexaptepid pegol as the first treatment for anemia of inflammation, the most common form of anemia.

Chronic Heart Failure Drug Designated Priority Review Status

The Food and Drug Administration (FDA) has granted Priority Review to Amgen's New Drug Application (NDA) for ivabradine for the treatment of chronic heart failure.

Aripiprazole Lauroxil NDA Submitted for Schizophrenia

Alkermes announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for aripiprazole lauroxil for the treatment of schizophrenia.

Ixekizumab vs. Etanercept for Plaque Psoriasis: Phase 3 Results Announced

Eli Lilly and Company announced results from its Phase 3 UNCOVER studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis, in which ixekizumab was found to be superior to etanercept.

Investigational Hemophilia A Therapy Sees Positive Results

Baxter announced positive results from its Phase 3 trial of BAX 855, an extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A.

Xiaflex Demonstrates Efficacy in Cellulite Study

Auxilium announced positive results from a Phase 2a study of Xiaflex (collagenase clostridium histolyticum [CCH]) for the treatment of edematous fibrosclerotic panniculopathy (EEP), also known as cellulite.

Positive Results for AMG 416 in Secondary Hyperparathyroidism Trial

Amgen announced results from its Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) receiving hemodialysis.

Combination Antibiotic Effective for Complicated Intra-Abdominal Infections

Actavis announced positive topline results from its Phase 3 studies, RECLAIM-1 and -2, evaluating the use of ceftazidime-avibactam for the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI).