Drugs in the Pipeline
Viaskin Peanut, an epicutaneous immunotherapy (EPIT), delivers small amounts of peanut protein through a wearable patch to induce desensitization.
The panel's decision was made based on data from from five Phase 3 studies and one Phase 4 trial which evaluated the safety and efficacy of prucalopride in patients with chronic constipation.
PRN1008 is an oral, reversible covalent Bruton's tyrosine kinase (BTK) inhibitor; BTK is present in the signaling pathways of most types of white blood cells except for T cells and plasma cells.
The Company stated that they plan to begin a Phase 2 trial of AXS-12 before the end of 2018, with results anticipated for the first half of 2019.
SUNRISE 2 is an ongoing long-term efficacy and safety study (N=900) of adults (aged 18 to 88 years) with insomnia disorder who have difficulty falling and/or staying asleep.
Alagille syndrome affects approximately 1 in 70,000 newborns.
Lynparza, a poly (ADP-ribose) polymerase (PARP) inhibitor, is being assessed in the ongoing Phase 3 POLO trial.
In both studies, at 24 weeks, patients treated with dupilumab plus corticosteroid nasal spray experienced a 51% and 57% improvement in nasal congestion/obstruction severity vs 15% and 19% improvement with nasal spray alone.
The NDA includes data from one Phase 2 and two Phase 3 clinical trials (STRIDE 1 and STRIDE 2) involving ~2000 individuals with dry eye disease.
X4 Pharmaceuticals is developing the drug, which is currently in a Phase 2/3 clinical trial involving patients with WHIM syndrome.
The FDA is not bound by the Committee's recommendation but takes it into consideration when making its decision.
STRO-001 targets CD74, which is a protein highly expressed in B-cell malignancies like multiple myeloma.
SNSP113 is intended to improve lung function in CF patients by targeting key drivers of pulmonary decline such as infection, airway congestion and inflammation.
Study authors at the American College of Gastroenterology (ACG) Scientific Meeting 2018 presented late-breaking data from the induction phase of the Phase 3 UNIFI study.
The NDA is based on data from the EXPAND study, a randomized, double-blind, placebo-controlled Phase 3 study in 1652 participants living with SPMS.
Renal and Urology News Articles
NEPHROLOGY & UROLOGY NEWS
- Acute Kidney Injury (AKI)
- Chronic Kidney Disease (CKD)
- Contrast Nephropathy
- Cardiovascular Disease (CVD)
- Diabetic Nephropathy
- End-stage Renal Disease (ESRD)
- Lupus Nephritis
- Peritoneal Dialysis
- Secondary Hyperparathyroidism (SHPT)