Company Product Description Indication Status
Amgen Inc., of Thousand Oaks, Calif. Otezla (apremilast)  PDE4 inhibitor  Behçet’s disease EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion to extend use for treating ulcers in patients with Behçet’s
Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn. Nurtec ODT (rimegepant) CGRP receptor antagonist formulated in orally disintegrating tablet Acute migraine Approved by FDA for use in adults
Boehringer Ingelheim GmbH, of Ingelheim, Germany Nintedanib Antifibrotic Systemic sclerosis-associated interstitial lung disease EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending granting marketing authorization in adults 
Debiopharm Group, of Lausanne, Switzerland Debio-1143 Antagonist of inhibitor of apoptosis proteins Squamous cell carcinoma of the head and neck FDA granted breakthrough therapy designation 
Eli Lilly and Co., of Indianapolis Emgality (galcanezumab) Monoclonal antibody targeting CGRP Episodic cluster headache EMA’s Committee for Medicinal Products for Human Use adopted a negative opinion to extend product’s indication for prevention of attacks in adults with episodic cluster headache
Fennec Pharmaceuticals Inc., of Research Triangle Park, N.C. Pedmark Formulation of sodium thiosulfate Prevention of cisplatin-induced ototoxicity in pediatric patients Received EMA validation for the MAA and it is now under evaluation
Innocoll Holdings Ltd., of Athlone, Ireland Xaracoll (bupivacaine HCl collagen-matrix implants) Drug-device anesthetic  Postsurgical pain Resubmitted NDA to FDA seeking approval for management of postsurgical pain after open inguinal hernia surgery; company anticipates a 6-month review 
Mereo Biopharma Group plc, of London Setrusumab Anti-sclerostin antibody Osteogenesis imperfecta Completed type B end-of-phase II meeting with FDA, which agreed to design of phase III pediatric study prior to submission of a BLA
Shionogi & Co. Ltd., of Osaka, Japan Fetcroja (cefiderocol)  Siderophore cephalosporin antibiotic  Aerobic gram-negative infections  EMA’s Committee for Medicinal Products for Human Use adopted positive opinion for use in treating adults with limited treatment options
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan Vedolizumab SC Subcutaneous version of alpha4beta7 integrin antagonist Moderately to severely active ulcerative colitis or Crohn’s disease EMA’s Committee for Medicinal Products for Human Use adopted a positive opinion for use as maintenance therapy in adults; Takeda proposes to make therapy available in both a prefilled syringe and a prefilled pen

Notes

For more information about individual companies and/or products, see Cortellis.

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