New Pipeline Updates from Pfizer, Sanofi and Acorda

January 7, 2019

Company Drug/Device Medical Condition Status
Pfizer, Inc. PF-06651600 (oral JAK3 inhibitor) moderate to severe alopecia areata Phase II/III trial initiated enrolling 660 subjects
Slayback Pharma LLC Hydroxyprogesterone Caproate Injection, USP 1,250 mg/ 5 ml risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth ANDA approval granted by the FDA
I-Mab Biopharma TJM2, a humanized immunoglobulin G1 (IgG1) targeting granulocyte-macrophage colony-stimulating factor (GM-CSF) autoimmune and inflammatory diseases IND approval granted by the FDA
Cardiva Medical, Inc. VASCADE MVP Venous Vascular Closure System electrophysiology procedures PMA approval granted by the FDA
Eiger BioPharmaceuticals, Inc. lonafarnib hepatitis delta virus (HDV) infection PRIME (PRIority MEdicines) designation granted by the EMA
Horizon Pharma plc RAVICTI (glycerol phenylbutyrate) Oral Liquid infants younger than two months of age living with a urea cycle disorder (UCD) sNDA approval granted by the FDA
Edwards Lifesciences Corporation SAPIEN 3 Ultra system transcatheter aortic valve replacement in severe, symptomatic aortic stenosis patients who are determined to be at intermediate or greater risk of open-heart surgery Approval granted by the FDA
Sanofi and Merck Vaxelis (ready-to-use hexavalent vaccine) prevention of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and invasive disease due to Haemophilus influenza type b Approval granted by the FDA
Alexion Pharmaceuticals Ultomiris paroxysmal nocturnal hemoglobinuria (PNH) Approval granted by the FDA
Stemline Therapeutics Elzonris blastic plasmacytoid dendritic cell neoplasm (BPDCN) Approval granted by the FDA
Teva Pharmaceutical Industries Ltd. ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder asthma and COPD Approval granted by the FDA
Acorda Inbrija intermittent treatment of OFF episodes in Parkinson’s disease patients taking Carbidopa/Levodopa Approval granted by the FDA
Merck KEYTRUDA recurrent locally advanced or metastatic Merkel cell carcinoma (MCC) Approval granted by the FDA
Veloxis Pharmaceuticals Envarsus XR (tacrolimus extended-release tablets) organ rejection in kidney transplant patients Approval granted by the FDA
AstraZeneca and Merck LYNPARZA deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer Approval granted by the FDA
Medtronic plc InterStim smart programmer overactive bladder (OAB), chronic fecal incontinence (FI) and non-obstructive urinary retention Approval granted by the FDA
Celltrion, Inc. and Teva Pharmaceuticals Industries Limited HERZUMA (trastuzumab-pkrb) treatment of HER2-overexpressing breast cancer for certain indications Approval granted by the FDA