Drugs in the Pipeline
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Rayaldee (calcifediol modified-release capsules, Opko) for the prevention and treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Sanofi announced that the Phase 3 trial of the fixed-ratio combination of insulin glargine 100 units/mL and lixisenatide met its primary endpoint in patients with type 2 diabetes treated with metformin.
The Food and Drug Administration (FDA) has accepted CSL Behring's Biologics License Application (BLA) for its novel investigational recombinant factor VIII single-chain (rVIII-SingleChain) for the treatment of hemophilia A.
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib for use in patients with advanced or metastatic renal cell carcinoma (RCC) who were previously treated with a vascular endothelial growth factor (VEGF)-targeted therapy.
The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for grazoprevir/elbasvir (Merck) for the treatment of adult patients infected with chronic hepatitis C virus (HCV) genotypes (GT) 1, 4, or 6.
Eli Lilly announced the continuation of the Phase 3 trial of evacetrapib in participants with high-risk atherosclerotic cardiovascular disease (ASCVD).
Adapt Pharma announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Narcan (naloxone) Nasal Spray for the treatment of opioid overdose.
Janssen Therapeutics announced the submission of a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) to update the label for once-daily, all-oral Olysio (simeprevir) in combination with sofosbuvir for adults with genotype 1 chronic hepatitis C (CHC) infection with or without cirrhosis.
The FDA has granted Fast Track designation to OMS721 (Omeros) for the treatment of patients with atypical hemolytic uremic syndrome (aHUS).
The sNDA for Kyprolis (carfilzomib, Amgen) was submitted to the FDA for the treatment of patients with relapsed multiple myeloma, who has received at least one prior therapy.