Drugs in the Pipeline

Drugs in the Pipeline

Elagolix Demonstrates Efficacy in 2nd Phase 3 Endometriosis Study

AbbVie and Neurocrine Biosciences announced positive top-line results from the second of two replicate Phase 3 clinical trials of Elagolix in premenopausal women with endometriosis-associated pain.

Orphan Drug Designation Granted to Novel Echinocandin

The Food and Drug Administration (FDA) has granted Orphan Drug designation to CD101 IV (Cidara Therapeutics) for the treatment of candidemia and invasive candidiasis.

FDA Designates Eltoprazine Orphan Drug in Parkinson's Disease

The Food and Drug Administration (FDA) has granted Orphan Drug designation for eltoprazine (Amarantus BioScience) in the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID).

FDA to Review Rexulti as Maintenance Therapy for Schizophrenia

The Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the proposed labeling update of Rexulti (brexpiprazole; Otsuka and Lundbeck) for the maintenance treatment of adults with schizophrenia.

Tazemetostat Granted Orphan Drug Status for Rare, Aggressive Cancers

The Food and Drug Administration (FDA) has granted Orphan Drug designation to tazemetostat (Epizyme) for the treatment of malignant rhabdoid tumors (MRTs).

Complete Response Letter Issued for Expanded Kalydeco Indication

The Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental New Drug Application (sNDA) of Kalydeco (ivacaftor; Vertex) in patients with cystic fibrosis (CF) ≥2 years old who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Top-line Results Announced for Repatha in Patients Who Are Statin-Intolerant

Amgen announced positive top-line data from the Phase 3 GAUSS-3 study evaluating Repatha (evolocumab) in statin-intolerant patients with high cholesterol.

Complete Response Letter Issued for MCNA in Bladder CA

The Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for MCNA (Telesta Therapeutics) in the treatment of non-muscle invasive bladder cancer (NMIBC).

Ovarian Cancer Vaccine Granted Fast Track Status

TapImmune announced that the Food & Drug Administration (FDA) has granted Fast Track designation for its cancer vaccine TPIV 200 in the treatment of ovarian cancer.

Investigational NASH Tx Fast Tracked by FDA

The Food and Drug Administration (FDA) has granted Fast Track designation to NDI-010976 (Nimbus Therapeutics) for the treatment of non-alcoholic steatohepatitis (NASH)