A month after getting approval in the USA, Shionogi says that regulators in Europe are reviewing the firm's ospemifene to treat women experiencing pain during sexual intercourse.
The recently-established London-based European subsidiary of the Japanese drugmaker announced that the European Medicines Agency has accepted its marketing authorisation application for ospemifene for the treatment of vulvar and vaginal atrophy in post-menopausal women. It is a pill taken with food once-daily which acts like oestrogen on vaginal tissues to make them thicker and less fragile.
Chief executive of Shionogi Limited, Takashi Takenoshita, said the acceptance of the MAA for ospemifene "not only represents an important step forward in expanding the treatment options for women living in Europe with this condition, but it is also an important milestone for Shionogi as it continues to build its business in Europe".
The filing in Europe comes after the US Food and Drug Administration approved the drug, called Osphena, based on three studies of almost 1,900 postmenopausal women. That green light came with a boxed warning which notes that the drug can stimulate the lining of the uterus and cause it to thicken, which is not normal in postmenopausal women, and states the risk of strokes and deep vein thrombosis.