ARTICLE | Clinical News

Manganese porphyrin regulatory update

February 3, 2014 8:00 AM UTC

Aeolus said FDA granted Orphan Drug designation to AEOL 10150 to treat or mitigate acute radiation syndrome in patients exposed to radiation following a nuclear accident or detonation. Aeolus is developing the product to treat pulmonary and delayed effects of acute radiation exposure under a 5-year contract with HHS's Biomedical Advanced Research and Development Authority (BARDA) (see BioCentury, Sept. 23, 2013). AEOL 10150 is being developed under FDA's Animal Rule, which allows marketing approval to be granted based on efficacy in relevant animal models and an acceptable safety risk profile in humans. ...