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Daewoong's Botox product accepted for review by EMA, FDA
  • By Constance Williams
  • Published 2017.07.21 16:43
  • Updated 2017.07.21 16:46
  • comments 0

Daewoong Pharma대웅제약’s NABOTA나보타(development name DWP-450), a Botulinum toxin Type A, has received confirmation from the European Medicines Agency (EMA) for the review acceptance for the marketing authorization application (MAA), its U.S.-based distributor said Friday.

Botulinum toxin Type A is a treatment for adult patients with glabellar lines, also known as “frown lines” between the eyebrows.

The review is supported by the results of phase 3 randomized, multicenter, placebo-controlled, double blind trial. Over 500 adult female and male subjects participated in the clinical trial that will be reviewed under the centralized procedure, which allows applicants to obtain a marketing authorization that is valid throughout the European Union.

Daewoong’s U.S. partner, Evolus Inc., has also received confirmation from the U.S. Food and Drug Administration that their biologics license application (BLA) has been accepted for review. More than 1,500 adult subjects participated in the clinical trials, and the BLA was submitted within three years of the first subject’s enrollment.

“Having the MAA and BLA acceptance for review marks a significant milestone achievement for the DWP-450 development program,” said Murthy Simhambhatla, CEO of Evolus. “We look forward to working with the FDA and the EMA during the agency’s review of the application.”

Daewoong signed a contract in 2013 to supply 300 billion won ($266 million) worth of botulinum toxin to the U.S., Europe, and Canada through Evolus.



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