PIPELINE

• Published in: Monthly Prescribing Reference Vol. 33; no. 8; p. A8
• Format: Trade Publication Article
• Language: English
• Published: New York Haymarket Media, Inc 01.09.2017
• Subjects: Drug dosages; Urogenital system
• ISSN: 0883-0266

*Allergic Disorders Epinephrine Auto-injector (AUVI-Q; Kaléo) first 0.1mg formu-lation designed to treat allergic reactions in infants and children weighing 16.5-33lbs-Priority Review granted to sNDA *Gastrohepatic Disorders Crofelemer (Mytesi; Jaguar Health/Napo) a first-in-class antisecretory agent under evaluation for the treatment of short bowel syndrome (SBS)-Orphan Drug Designation granted *Hematological Disorders Caplacizumab (Ablynx) a first-in-class bivalent, anti-von Willebrand factor (vWF) Nanobody being developed for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP)-Fast Track Designation granted immunization UTI vaccine (Sequoia Sciences) an investigational vaccine being evaluated for recurrent urinary tract infections (UTIs) caused by multi-drug resistant bacteria-Fast Track Designation granted VLA15 (Valneva) a protein subunit-based vaccine under development for Lyme disease-Fast Track Designation granted infectious Diseases Bictegravir/emtricitabine/tenofovir alafenamide (Gilead) a fixed-dose, single-tablet regimen, consisting of a novel integrase strand transfer inhibitor with a dual-NRTI backbone, for the treatment of HIV-1 infection-Priority Review granted to NDA Meropenem/vaborbactam (Vabomere; The Medicines Company) a fixed-dose antibiotic combination, consisting of a carbapenem and a novel beta-lactamase inhibitor being assessed for the treatment of carbapenem-resistant Enterobacteriaceae (CRE) infections of blood, lung, urinary tract, and abdominal organs-Phase 3 VT-1598 (Viamet) a novel, oral fungal CYP51 inhibitor being studied for the treatment of Valley Fever, also known as coccidioidomycosis-Fast Track Designation granted *Metabolic Disorders SOBI003 (Sobi) a chemically modified variant of a recombinant human sulfamidase candidate under development for mucopolysaccharidosis type IIIA-Orphan Drug Designation granted Oxalate decarboxylase (ALLN-177; Allena) a first-in-class, oral, non-absorbed recombinant enzyme in early studies for the treatment of primary hyperoxaluria- Orphan Drug Designation granted *Neurologic Disorders FLX-787 (Flex Pharma) investigational TRPA1 and TRPV1 coactivator in clinical development for the treatment of severe muscle cramps in patients with amyotrophic lateral sclerosis (ALS)-Fast Track Designation granted Fenfluramine (ZX008; Zogenix) a novel, low-dose liquid formulation intended for the treatment of Lennox Gastaut Syndrome (LGS)-Orphan Drug Designation granted *Ob/Gyn Ethinyl estradiol/levonorgestrel (Twirla; Agile Therapeutics) a low-dose, combined hormonal contraceptive patch designed for once-weekly administration-NDA Resubmitted *Pain Management Lasmiditan (Eli Lilly) an oral, selective 5-HT1F receptor agonist being evaluated in clinical trials for the acute treatment of migraines without vasoconstrictor activity-Phase 3 *Poisoning & Drug Dependence Buprenorphine Depot (RBP-6000; Indivior) a sustained-release injectable form for the treatment of opioid use disorder-Phase 3 *Respiratory Disorders Revefenacin (TD-4208; Theravance/Mylan) a once daily nebulized long-acting muscarinic antagonist (LAMA) being investigated for the treatment of COPD-Phase 3 *Brand names and all other information are subject to change before the product launches.