Avexa Reaches Agreement With U.S. Regulator
Australia's Avexa Ltd. says its new agreement with the US Food and Drug Administration means the "regulatory pathway to final approval" of its HIV drug apricitabine (ATC) has been agreed upon. "Most importantly, the FDA has recognized and given credit for the significant amount of previous ATC clinical studies conducted by Avexa, in particular the latest ATC study AVX-301," the company said. "As a consequence, the remaining regulatory requirements for an ATC approval are considerably less complicated and less extensive than previously assumed, and less than that required for other recently approved drugs." Avexa said its research has shown "great potential" for the use of ATC in patients with multidrug-resistant HIV.