New Pipeline Updates from Eli Lilly, Merck, AbbVie and Lumendi

November 19, 2018

Company Drug/Device Medical Condition Status
Stallergenes Greer Oralair®, an allergy immunotherapy sublingual tablet Grass pollen-induced allergic rhinitis Received FDA approval for the extension of the indication to treat patients ages five to nine
REGENXBIO RGX-181, a one-time treatment candidate Late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, one of the most common forms of Batten disease Granted Orphan Drug Designation by the FDA
Eli Lilly and Company Lasmiditan Migraine with or without aura in adults Submitted a New Drug Application (NDA) to the FDA
Eli Lilly and Company Emgality Episodic cluster headache Granted Breakthrough Therapy Designation by the FDA
Lumendi DiLumen™ EIP Easier dissection and resection of polyps without the need for surgical intervention Received 510(k) clearance from the FDA
Theravance Biopharma, Inc. and Mylan N.V. YUPELRITM (revefenacin), once-daily, nebulized bronchodilator COPD Granted approval by the FDA
Biohaven Pharmaceutical Holding Company Ltd Rimegepant, oral calcitonin gene-related peptide (CGRP) receptor antagonist Migraine Enrolled first patient in Phase III clinical trial
AbbVie Mavyret (glecaprevir/pibrentasvir) Hepatitis C (HCV) Results from Phase IIIb EXPEDITION-8 trial: patients receiving the drug for 8 weeks with genotype 1, 2, 4, 5 and 6 had a 100-percent sustained virologic response 12 weeks after treatment
Merck KEYTRUDA® (PEMBROLIZUMAB) Advanced or metastatic esophageal or esophagogastric junction carcinoma in patients whose tumors expressed PD-L1 Significantly improved Overall Survival (OS) compared to chemotherapy in Phase III KEYNOTE-181 clinical trial
AbbVie Elagolix, in combination with add-back therapy Heavy menstrual bleeding associated with uterine fibroids Achieved statistically significant reduction in two replicate pivotal Phase III clinical trials
Calliditas Therapeutics NEFIGARD IgA nephropathy (IgAN) First patient enrolled in pivotal Phase III clinical trial
Palvella Therapeutics, Inc. PTX-022 (novel, high-strength rapamycin topical formulation Pachyonychia congenita (PC) Granted Fast Track Designation by the FDA
TWi Biotechnology, Inc. AC-201CR Hemophilic arthropathy Completed patient enrollment in Phase II clinical trial