Cumberland Pharmaceuticals’ Ifetroban Secures the US FDA’s ODD and RPDD for Duchenne Muscular Dystrophy
Shots:
- The US FDA has granted ODD & RPDD to ifetroban for treating cardiomyopathy related to Duchenne muscular dystrophy (DMD)
- Ifetroban (QD, oral) is a selective thromboxane-prostanoid receptor (TPr) antagonist being investigated under P-II (FIGHT DMD) study for its safety, efficacy & PK in DMD patients, with results anticipated during Q4’24
- The company is also conducting another P-II (FIGHTING FIBROSIS) study for assessing the safety & efficacy of ifetroban vs PBO in patients with idiopathic pulmonary fibrosis (IPF) for over 52wks.
Ref: Cumberland Pharmaceuticals | Image: Cumberland Pharmaceuticals
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com