In the letter, the FDA indicated that at least one additional clinical trial, and a re-read of images obtained in previously completed phase III trials, will be necessary before the agency could approve Vasovist. No safety or manufacturing issues were raised in the approvable letter.
This is the second approvable letter Epix has received from the FDA since the company’s new drug application for Vasovist was filed in December 2003. In May 2005 the company submitted a response to the FDA’s first approvable letter which the FDA accepted as a “complete response” in June 2005.
“While we are disappointed that the FDA did not approve Vasovist at this time, we continue to believe that Vasovist will be an important drug that will be approved by the FDA,” stated Michael Astrue, Epix interim chief executive officer.
Mr Astrue then went on to say that in light of the FDA decision the company has decided to “reduce substantially our research efforts and our employment levels,” a move that Mr Astrue says will cut the company’s expenditure and allow it to focus on advancing its two lead products.
In October 2005, Vasovist was approved in all EU member states, making it the first in a new class of blood-pool contrast agents for magnetic resonance angiography (MRA) to diagnose vascular disease. Under the European labeling, Vasovist is indicated for visualization of abdominal or limb vessels in patients with known or suspected vascular disease such as stenosis or aneurysms.
Vasovist was co-developed under a strategic partnership with Epix Pharmaceuticals. Schering AG has the global marketing rights for the product and said in a statement that it will continue to support Epix in its efforts to address the requests of the FDA.