Mallinckrodt announced the completion of its rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for terlipressin for the treatment of hepatorenal syndrome type 1 (HRS-1).
The FDA has granted Fast Track designation for empagliflozin (Jardiance; Boehringer Ingelheim and Lilly) to reduce the risk of kidney disease progression and cardiovascular (CV) death in adults with chronic kidney disease.
Invokana is now approved to reduce the risk of end-stage renal disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic nephropathy with albuminuria >300mg/day.
Even though overall drug development times have not changed, questions about the clinical benefit of the drugs that have been approved through expedited pathways are being raised.
Full study results will be presented at an oral plenary session at the OxalEurope International Congress on Tuesday, March 31, 2020.
Drug found to be superior in maintaining proteinuria remission for up to 24 months
Benefit-risk profile superior to vitamin K antagonists for early-stage chronic kidney disease
The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to DCR-PHXC (Dicerna Pharmaceuticals) for the treatment of patients with primary hyperoxaluria type 1 (caused by a mutation in the AGXT gene). DCR-PHXC is a ribonucleic acid interference (RNAi) investigational treatment that works by inhibiting the lactate dehydrogenase A enzyme (LDHA) in the liver…
Adults ≥66 years old who received sodium polystyrene sulfonate in an outpatient setting between April 1, 2003 and September 30, 2015 were included in the analysis.
A recently published report describes the case of a 62-year-old patient who experienced rare but serious central nervous system (CNS) side effects following the initiation of gabapentin therapy.
