Today's the big day for Boehringer Ingelheim, which will take its likely blockbuster drug Pradaxa through the gamut of FDA experts. Last Thursday FDA staffers pushed for an approval of the higher of two doses of Pradaxa--150 mg--as a treatment to prevent strokes in patients with an irregular heartbeat. But the 110 mg dose was dissed, a factor which could play havoc with Boehringer's strategy to compete with Xarelto (J&J) and apixaban (BMS, Pfizer) as the cream of next-generation successors to the standard warfarin.
As Pharmalot notes this morning, the staff review presents Boehringer with some troubling problems. Larry Biegelsen of Wachovia Securities says that a solo approval for the 150 mg dose leaves Pradaxa more vulnerable to competition from Xarelto. Credit Suisse analyst Catherine Arnold, meanwhile, thinks that the company's decision to submit an open label study for approval leaves them vulnerable to any competitor who can prove superiority. And in Canada, where Xarelto and Pradaxa are both available in acute settings, Xarelto has won the upper hand.
The stakes are huge. The market for these drugs is likely to stretch from $10 billion to $20 billion. Doctors, though, will decide who wins in the U.S. And a sudden rush of new drugs after decades of domination by warfarin could prove dizzying.
"This space will get complicated very quickly now because you will be dealing with drugs that have different mechanisms," Clyde Yancy, past president of the American Heart Association, told Reuters late last month. "I think many practitioners will become perplexed, confused, and the real concern is: are we at risk of making some major mistakes here? The complications are very real if you are dealing with bleeding risk."
- here's the story from Pharmalot