En marzo la EMA lo acepta...MOUNTAIN VIEW, Calif., March 26, 2012 (GLOBE NEWSWIRE)
VIVUS,Inc. today announced that a Marketing Authorization Application (MAA) has been accepted by the European Medicines Agency (EMA) for the review of avanafil, its investigational drug for the treatment of erectile dysfunction(ED). The EMA submission follows the successful completion of an extensive phase 3 program for avanafil, which included over 1,350 patients.
"The unique profile of avanafil, including its onset of action and highly selective profile, make it an attractive treatment alternative for the more than 20 million European men suffering with ED," stated Francesco Montorsi, MD, Professor of Urology and Director of the Urology Research Institute at the Universita' Vita e Salute San Raffaele in Milan, Italy. "Successful intercourse was reported in some patients in as little as 15 minutes after dosing. The comprehensive results from the development program suggest avanafil, if approved, could effectively compete in the $4 billion worldwide ED market."
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