Recent Developments
On February 12, 2024, Takeda Pharmaceutical Company Limited, a multinational pharmaceutical company, announced that the U.S. Food and Drug Administration has approved Eohilia (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE) in patients aged 11 years and older. The regulatory move makes Eohilia the first and only approved oral medication for this patient population, and Takeda Pharmaceutical Company Limited expects Eohilia 2 mg/10 mL single-dose stick packs to be available by the end of February 2024.
On January 30, 2024, Revolo Biotherapeutics, a biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has given Orphan Drug Designation (ODD) to '1104, a first-in-class immune-resetting peptide being researched as a potential treatment for eosinophilic esophagitis. Revolo submitted its initial request prior to the start of its Phase 2a EoE trial (RVLO 121-04) and revised it following the positive results of an additional Phase 2 study.
On January 25, 2024, Regeneron Pharmaceuticals, Inc., a leading biotechnology company, and Sanofi, a pharmaceutical and healthcare company, announced that the U.S. FDA has approved Dupixent (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in pediatric patients aged 1 to 11 years weighing at least 15 kg. Dupixent is presently the first and only drug approved in the U.S. exclusively for treating these patients.
On January 8, 2024, Calypso Biotech BV, a leader in the development of Interleukin-15 (IL-15) targeted therapies, announced that it has entered into an agreement to be acquired by Novartis AG, a pharmaceutical company. Novartis AG now owns complete rights to CALY-002. Novartis AG plans to further investigate CALY-002 in a wide range of autoimmune diseases with significant unmet medical needs. CALY-002 is now being tested in a Phase 1b trial for patients with Celiac Disease and Eosinophilic Esophagitis.
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