Eli Lilly's Arxxant gets FDA approvable letter

US drug major Eli Lilly says that it has received a Food and Drug Administration approvable letter for its diabetic retinopathy medication ruboxistaurin mesylate, which has the proposed trade name Arxxant. In its letter, the FDA has asked for further data in support of the clinical evidence it submitted in its original New Drug Application (Marketletter August 8, 2005).

DR occurs when diabetes causes damage to the small blood vessels of the retina, leading to vision loss. The drug is believed to mediate its effect by limiting the function of the enzyme protein kinase C beta, the action of which is associated with the development of the condition.

In response, Lilly said that it would work closely with the FDA to determine if this requirement can be satisfied with data from ongoing research, or if an additional study is necessary. The firm's share price dropped $0.85 to $55.10 during premarket electronic trading on the INET of the New York Stock Exchange, on August 17..