Another setback for Lilly's blindness drug

By Mike Nagle

- Last updated on GMT

Related tags Food and drug administration Pharmacology

Eli Lilly & Co has withdrawn its European approval application
for Arxxant (ruboxistaurin), a potential blockbuster drug to treat
blindness caused by diabetes.

The European Medicines Agency (EMEA) announced that the US pharma firm has pulled its application for a centralised marketing authorisation for the first-in-class drug. Arxxant was developed to prevent protein kinase C beta from functioning - an enzyme thought to contribute to the blood vessel damage caused by diabetes. Nearly 75 per cent of all people with diabetes suffer from complications leading to blood vessel damage. If the subsequent bleeding is found in the eye, the condition is called diabetic retinopathy. It is the most common diabetic eye disease and, according to the World Health Organisation, it is the leading cause of blindness in adults of working age (20 to 65 years) in industrialised countries. Although it can be treated by laser surgery, there is currently no specific treatment designed to target its cause. Lilly's decision is just the latest in a string of set backs for the drug. Around 18 months ago, the drug failed two Phase III trials aimed at assessing its effectiveness at treating nerve deterioration, again caused by diabetes (diabetic peripheral neuropathy). However, at the time, the company did see better results in a Phase III diabetic retinopathy trial and so submitted a new drug application to US regulators at the Food and Drug Administration (FDA). At the time, Dr Steven Paul, vice president of science and technology at the company, said: "While we are disappointed in the outcome of the trials for SDPN, we are extremely pleased to be one step closer to providing a possible solution for patients with diabetic retinopathy." "If ruboxistaurin is approved by the FDA, it would be the first oral medication for the treatment of this serious complication of diabetes,"​ he added. However, the regulators didn't agree and last September they rejected the application pending an additional, three-year, Phase III study, leaving the pharma company once again "disappointed"​. Lilly decided to appeal the decision but just this week was dealt another blow when the FDA rejected the appeal. Since then, the company has announced it does not intend to persue the appeal further. This latest setback is not down to another request for further research though. Lilly said that the withdrawal of Arxxant was because it could not respond to the Agency's request for additional information within the allowed timeframe.

Related topics Preclinical Research

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