Eli Lilly says it will appeal the FDA’s decision to issue an “approvable letter” that requests an additional efficacy study for Arxxant, its new drug for moderate to severe nonproliferative diabetic retinopathy. Its appeal will be based on unmet medical need for the drug, demonstrated efficacy and Arxxant’s “robust safety profile.”
From the December 01, 2006 Issue of MM+M - Medical Marketing and Media
