Drugs in the Pipeline

Drugs in the Pipeline

Microbiota Restoration Tx Designated Breakthrough Therapy for CDI

The FDA has granted Breakthrough Therapy designation to RBX2660, a Microbiota Restoration Therapy (MRT), for the treatment of recurrent Clostridium difficile infection (CDI).

Mino-lok Granted QIDP Designation for Infected Catheters

The FDA has granted Qualified Infectious Disease Product (QIDP) designation for the antimicrobial lock solution, Mino-Lok (minocycline-EDTA-EtOH; Leonard Meron Biosciences), to salvage and sterilize infected central venous catheters (CVCs) in patients with bacteremia.

Study on Investigational Cholesterol Drug Halted

Eli Lilly announced the termination of its Phase 3 study, ACCELERATE, for the investigational drug evacetrapib, due to insufficient efficacy for the treatment of high-risk atherosclerotic cardiovascular disease (ASCVD).

Cinryze Fast Tracked for Antibody Mediated Rejection

The FDA has granted Fast Track designation to Cinryze (C1 esterase inhibitor [human]; Shire) as an adjunct to Donor Specific Antibodies (DSA) reduction therapy in renal transplant patients with acute Antibody Mediated Rejection (AMR).

Kalydeco sNDA Granted Priority Review for Expanded Indication

The Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) of Kalydeco (ivacaftor; Vertex) for the use in patients with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations.

Single-Dose Antibiotic for ABSSSI, Including MRSA, Accepted for Review

The FDA has accepted for filing the supplemental New Drug Application (sNDA) for Dalvance (dalbavancin; Allergan) to expand its label to include single-dose administration for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults caused by designated susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

New Drug for Tardive Dyskinesia Demonstrates Efficacy in Phase 3 Study

Neurocrine Biosciences announced positive results from its Kinect 3 study, showing that NBI-98854 achieved a statistically significant reduction in tardive dyskinesia during the 6 weeks of treatment in patients with underlying schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder.

Abemaciclib Granted Breakthrough Tx for Advanced Breast Cancer

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to abemaciclib (Lilly) for patients with refractory hormone-receptor-positive (HR+) advanced or metastatic breast cancer.

FDA Grants Avelumab Fast Track Status for Aggressive Skin Cancer

The Food and Drug Administration has granted avelumab (Pfizer/Merck) Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.

Guadecitabine Granted Orphan Drug Status for MDS or AML

The Food and Drug Administration (FDA) has granted Orphan Drug designation to guadecitabine (SGI-110; Astex) for the potential treatment of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML).