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New Pipeline Updates from Akcea Therapeutics, Genentech, Eximo Medical and Valneva USA

October 15, 2018

Company Drug/Device Medical Condition Status
Akcea Therapeutics TEGSEDITM (inotersen) Polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults Granted approval by the FDA
Akcea Therapeutics AKCEA-APO(a)-LRx Cardiovascular disease (CVD) and elevated levels of lipoprotein(a), or Lp(a) Positive topline results from a Phase II clinical trial
Bausch Health Companies, Inc. BRYHALI™ (halobetasol propionate) Lotion, 0.01% Plaque psoriasis in adults FDA tentatively approved New Drug Application; final OK pending expiration of exclusivity for related product
Eximo Medical Ltd B-Laser™ Atherectomy System Peripheral artery disease (PAD) Granted 510(k) clearance by the FDA
YiSheng BioPharma Co. PIKA® rabies vaccine Rabies Granted clearance by the China FDA to proceed with a clinical trial
Genentech Hemlibra Hemophilia A patients without factor VIII inhibitors Granted approval by the FDA
Leadiant Biosciences, Inc. Revcovi™ (elapegademase-lvlr) injection Adenosine deaminase severe combined immune deficiency (ADA-SCID) in children and adults Granted approval by the FDA
Breckenridge Pharmaceutical, Inc. Roflumilast Tablets, 500mcg (generic for Daliresp® Tablets) COPD Abbreviated New Drug Application approved by the FDA
Valneva USA XIARO® (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) Japanese encephalitis Accelerated dosing regimen approved by the FDA
Eidos Therapeutics, Inc. AG10 amyloidosis (ATTR) Granted Orphan Drug designation by the FDA
Paratek Pharmaceuticals, Inc. NUZYRA™ (omadacycline) Community-acquired bacterial pneumonia; acute skin infections (ABSSSI) in adults Granted approval by the FDA
Poxel SA Imeglimin, an investigational therapeutic agent Type 2 diabetes Patient enrollment completed in the TIMES 2 trial of the Phase III registration program
Chugai Pharmaceutical Co., Ltd HEMLIBRA® (US generic name: emicizumab-kxwh) Hemophilia A without factor VIII inhibitors in newborns, children and adults Granted approval by the FDA
Genentech baloxavir marboxil Influenza type A/H3N2 and type B Phase III CAPSTONE-2 trial showed symptoms improved significantly faster in patients at high risk of serious flu who took the drug v. a placebo
Zealand Pharma A/S Glepaglutide Short bowel syndrome (SBS) First patient enrolled in a global Phase III trial