Drugs in the Pipeline
The NDA submission included data from two Phase 3 trials, SAMURAI and SPARTAN.
Glecaprevir/Pibrentasvir 8-Week Regimen Evaluated in Treatment-Naïve HCV Patients With Compensated Cirrhosis
In EXPEDITION-8, 280 treatment-naïve HCV patients (genotypes 1, 2, 4, 5, and 6) with compensated cirrhosis were treated with Mavyret for 8-weeks; the primary efficacy measure was SVR12 rate.
NRX-101 combines D-cycloserine (DCS), an N-methyl-D-aspartate (NMDA) receptor antagonist, and lurasidone, a D2/5-HT2a receptor antagonist.
Through Palvella's proprietary QTORIN formulation, PTX-022 targets basal keratinocytes, which harbor the mutant keratin genes that cause PC.
The Company states that in vivo tests have shown that the compound's pain suppressing efficacy is comparable to morphine.
The designation was granted to Revive Therapeutics, a company that specializes in cannabis-based pharmaceuticals.
The Company is planning a Phase 3 study (DeFi) sometime in the first half of 2019.
Doptelet is a thrombopoietin receptor agonist (TPO-RA) that was approved in May 2018 to treat thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure.
Dupixent is also being assessed in other allergic/inflammatory conditions, including pediatric atopic dermatitis, pediatric asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, grass allergy, and peanut allergy.
The treatment is designed to deliver pain relief directly to the site of tissue injury, thereby potentially reducing the need for systemically administered pain medications.
Contepo, an investigational epoxide intravenous (IV) antibiotic, has broad spectrum activity against Gram-negative and Gram-positive pathogens, including multi-drug resistant strains such as ESBL-producing Enterobacteriaceae.
Two Phase 3 trials conducted in Asia and Latin America assessed the efficacy of the vaccine in >35,000 individuals aged 2 to 16 years.
UGN-1 is an investigational formulation of mitomycin, delivered to patients using standard intravesical catheters.
The decision was made after results from a Phase 3 trial (N=44) comparing UX007 to placebo did not show a statistically significant reduction in paroxysmal movement events in favor of the treatment (primary endpoint).
The sNDA included data from the REACH1 study (N=71) which evaluated ruxolitinib in combination with corticosteroids in patients with steroid-refractory acute GVHD.
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)