Novartis digs into safety data in Avastin-vs.-Lucentis study

Novartis ($NVS) couldn't let the Avastin-vs.-Lucentis study pass by without comment. Two-year data from that head-to-head trial, funded by the National Eye Institute, showed that the two drugs were evenly matched at improving AMD patients' vision. Given the fact that Avastin is far cheaper, the study could inspire more ophthalmologists to use it, despite its lack of regulatory clearance for that indication.

For Novartis, which markets Lucentis outside the U.S., that would mean losing patients--and revenue. And it's already fighting off-label Avastin use. Just last week, it struck out at the U.K.'s National Health Service, which counts Lucentis as its only official wet AMD treatment, but has turned to Avastin in some local areas.

So, after the NEI study update hit yesterday, Novartis dug into the data on side effects. According to its analysis, Avastin patients had a 30% higher risk of serious systemic side effects than Lucentis patients did. The side effects that cropped up in Avastin users--including blood clots, congestive heart failure and gastrointestinal disorders--have been seen before, in studies of the drug in cancer patients. And, says Novartis, the NEI study wasn't set up to track "infrequent but serious events" such as death and stroke that were previously found in Medicare data analyses.

Roche ($RHHBY), which developed Lucentis, has said the eye drug was designed to clear quickly from the body, to help prevent those systemic side effects. "Novartis puts patient safety first and believes Lucentis is the best treatment option for patients with wet AMD," the company said in a statement. "Novartis believes that, within regulatory guidelines, the unlicensed use of drugs should be limited to cases where there is an unmet medical need which cannot be fulfilled by licensed medications." That unmet need wouldn't, of course, include cutting healthcare costs.

- read the statement from Novartis