Drugs in the Pipeline
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.
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).
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.
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.
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.
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).
The Food and Drug Administration (FDA) has granted Fast Track designation to TXA127 (angiotensin 1-7; Tarix Orphan) to reduce skeletal muscle damage and fibrosis and thereby improve muscle strength in Duchenne Muscular Dystrophy (DMD) patients.
The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to three supplemental New Drug Applications (sNDAs) for Daklinza (daclatasvir; BMS) for use with sofosbuvir with or without ribavirin for the treatment of patients with chronic hepatitis C (HCV) co-infected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.
Eli Lilly and Incyte announced positive top-line results of RA-BEGIN, the third Phase 3 study evaluating the safety and efficacy of baricitinib for the treatment of patients with moderately-to-severely active rheumatoid arthritis (RA).
The Food and Drug Administration (FDA) has accepted for filing with Priority Review the New Drug Application (NDA) for defibrotide for the treatment of patients with hepatic veno-occlusive disease (VOD) with evidence of multi-organ dysfunction (MOD) following hematopoietic stem-cell transplantation (HSCT).
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