Anthera Reaches Agreement With FDA for Phase III Protocol of Coronary Drug
Anthera Pharmaceuticals has reached an agreement with the FDA on a Phase III protocol for varespladib in acute coronary syndrome under the FDA’s special protocol assessment procedure.
At the same time, the company has received scientific advice from the European Medicines Agency (EMEA) on Anthera’s European development strategy for varespladib. Anthera has said that the guidance from both regulatory agencies regarding varespladib will be incorporated into the company’s global registration program slated to start in 2009.
Anthera’s special protocol assessment supports a single, pivotal, Phase III trial evaluating varespladib, in combination with Lipitor (atorvastatin) as first-line treatment within 96 hours of an acute coronary syndrome (ACS) event.
In the EU, Anthera has received scientific advice that supports a similar clinical development program and includes the potential to also utilize varespladib as an adjunctive treatment in patients with stable coronary disease and elevated levels of LDL-C and total cholesterol.
In previous clinical trials, varespladib, a potent and highly selective inhibitor of secretory phospholipase A2 (sPLA2), has demonstrated marked improvements in independent markers of cardiovascular risk including, a near complete suppression of the target enzyme sPLA2, clinically meaningful and statistically significant reductions in ‘bad’ LDL cholesterol, and a reduction in C-reactive protein, a known marker of inflammation.
Ursula Fritsch, vice president of global regulatory and compliance, Anthera, said: “The regulatory clarity in the US and Europe reinforces our confidence that we can efficiently deliver a novel therapeutic for patients with ACS. With this regulatory feedback, we have a clearly defined and reasonable development path to deliver a first in class therapeutic for ACS patients and individuals with hypercholesterolemia.”