Lilly to appeal FDA's approvable letter for Arxxant

Share this article:
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."
Share this article:

Email Newsletters

More in News

Allergan touts reorg, plans to lay off 13% of workforce

Allergan touts reorg, plans to lay off 13% ...

Allergan's second-quarter earnings, and a new round of cuts, are now part of the Botox maker's record as it seeks to remain independent.

Shire, AbbVie join forces for $55B

Shire, AbbVie join forces for $55B

The deal includes a $1.6-billion fee if AbbVie tries to walk away.

Next target for hep. C drugmakers: co-infections

Next target for hep. C drugmakers: co-infections

An international AIDS conference this weekend kicked off a new battle in the war against hepatitis C: demonstrating high cure rates in those who are co-infected.