ALPHAEON submits biologics license application for DWP-450 neuromodulator BLA submitted within three years of first patient enrolment

ALPHAEON

16 May 2017 - ALPHAEON today announced that its wholly-owned subsidiary Evolus, submitted a biologics license application for DWP-450, a Botulinum toxin type A, to the U.S. FDA seeking approval for the treatment of adult patients with glabellar lines, also known as “frown lines” between the eyebrows.

The submission is based on the results of two open label, repeat dose, long-term Phase II studies (EV-004 and EV-006) and two Phase III randomised, multi-centre, placebo-controlled, double blind trials (EV-001 and EV-002). In total, over 1,500 adult male and female subjects participated in the clinical program and the BLA was submitted within three years of the first subject’s enrolment.

Read ALPHAEON press release

Michael Wonder

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Michael Wonder

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Medicine , Submission , Biosimilar