FDA says Novartis’ Prexige ‘not approvable’

Novartis said it has received a “not approvable” letter from the FDA for its COX-2 inhibitor Prexige (lumiracoxib) as an arthritis treatment.

The drugmaker said plans to continue discussions with FDA and believes Prexige  is “a valuable treatment option for appropriate patients with osteoarthritic pain.”

Novartis had touted Prexige as a potential blockbuster, with hopes for sales of over $1 billion a year, but CEO Daniel Vasella said earlier this month that the drug was a long shot to gain US approval after Australian regulators decided to withdraw it from the market in early 2007 due to safety concerns.

Recent setbacks for Novartis mean the company doesn’t expect to return to double-digit sales growth until the second half of 2008, Vasella told investors last month.

“We had a significant number of disappointments,” Vasella said in a published report. We “will have a much less dynamic year in the pharma business in the second half (than in the first), which will affect the group as a whole.”