VENUS II Paves Way For Allergan's Ulipristal NDA In Uterine Fibroids
Ulipristal meets all primary and secondary endpoints in the pivotal VENUS II study, supporting an NDA for uterine fibroids in the second half of 2017.
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Another hectic 12 months are anticipated at the US FDA as it is set to give its verdict on no fewer than 40 products in 2018. Here Scrip takes a look at 10 of the more interesting candidates approaching the market for the first time.
Phase III data show statistically significant wrinkle-reducing results for up to six months across two trials for Revance's neuromodulator RT002. With a safety study ongoing, the Botox competitor isn't likely to hit the market until 2020, but it's yet another piece of bad news for Allergan.
Allergan is working on a plan to reduce costs now that Restasis generics could hit the US market in 2018, but the company said sales growth for other drugs coupled with new product launches will boost revenue even if the dry eye drug loses its blockbuster status.