Experimental eye drug ruboxistaurin in limbo

Indianapolis-Late last month, the FDA rejected Eli Lilly & Co.’s appeal of a ruling mandating more tests to determine whether its drug ruboxistaurin (Arxxant) is effective in treating eye disease in patients with diabetes.

Based on the denial, the company does not plan to proceed with the appeal, according to a spokesperson. “While we’re obviously disappointed with the FDA’s decision, we will not pursue this appeal further,” said Lee Lange, communications manager–product communications.

In 2006, the FDA ruled that the experimental drug did not meet approval and that the company would need to conduct a new 3-year clinical study. The company appealed, contending that such a move would delay the drug’s market entrance by at least 5 years.

As a result of the latest FDA ruling, the company said it would review its options, including new trial initiations, teaming with a partner to subsidize costs, or discontinuing the efforts altogether.

The company has invested 10 years in the development of ruboxistaurin, which blocks an enzyme heavily involved in the microvascular damage caused by diabetes. Clinical trials showed minimal benefit, however, according to the FDA.

The company said it also would retract its application for approval in the European Union for now, because it is not ready to submit requested data by the established deadline.