Novartis has pushed back the projected NDA filing timeline for the COX-2 inhibitor Prexige on the assumption that FDA will require two-year cardiovascular data in the post- Vioxx era.

Novartis currently expects to resubmit the lumiracoxib NDA in 2007; the company previously had projected a filing in late 2005 or early 2006. Prexige was deemed "not approvable" in September 2003 pending additional data.

"We have shifted the filing date for Prexige from 2006 into 2007," Novartis said during an Oct. 21 earnings call.

"We believe it's prudent at the moment to expect that further cardiovascular data may be requested and this shift would reflect an additional two-year trial," the company said. "Obviously, if the trial has to be longer than two years, we would have to look at the timeline again."

Merck withdrew Vioxx (rofecoxib) from the market Sept. 30 after data from a colon polyp study showed an increased risk of cardiovascular events after 18 months of treatment.

At the time of the Vioxx withdrawal, FDA said it would seek long-term data for COX-2 inhibitors in the pipeline as well as those on the market (¹ Also see "FDA Will Require Additional Long-Term Data For COX-2 Inhibitors" - Pink Sheet, 30 September, 2004.).

"We have not had clear guidance from the FDA as to what new, if any, studies they would expect us to do," Novartis said.

The company said it expects to have "more detailed discussions" with the agency in early 2005 after FDA completes its review of 12-month data from the TARGET study, an 18,000-patient trial that compared Prexige to ibuprofen and naproxen.

The study found that Prexige users had fewer gastrointestinal side effects compared to those receiving nonsteroidal anti-inflammatory drugs.

The study showed a nonstatistically significant increase in myocardial infarctions among patients in the Prexige arm compared to the naproxen group (² Also see "Prexige TARGET Study: Not Quite A Bull's-Eye For Novartis" - Pink Sheet, 19 August, 2004.).

"The FDA is currently looking at that trial," Novartis said. "They have not completed their review. We get additional questions regarding TARGET, which we are currently answering, so we are in active discussions with the FDA, but we have no clear guidance as to what potential additional data they would like to see from a cardiovascular perspective."

The safety data requirements for COX-2 inhibitors are likely to be further clarified following an FDA advisory committee meeting on the issue in early 2005 (³ Also see "FDA To Hold COX-2 Advisory Committee In Early 2005, Woodcock Says" - Pink Sheet, 19 October, 2004.).

- Sue Sutter

Prexige 2007 Filing Target Assumes FDA Will Request Additional CV Data

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