drugset / Press release

The U.S. 3-phase clinical results of ‘Jeuveau’ is published on an SCI-level international journal

2019-03-25 · Daewoong Pharmaceutical Co. LTD. · original daewoong.co.kr ↗

The U.S. 3-phase clinical results of ‘Jeuveau’ is published on an SCI-level international journal - Published on the March issue of Dermatologic Surgery, an authoritative international journal. - Superior improvement in wrinkle and safety proven compared to placebo as a result of the U.S. 3-phase EV-001 and EV-002. Daewoong Pharmaceutical (CEO Sengho Jeon) has announced that the U.S. 3-phase trial results of Jeuveau (Nabota) were published on ‘Dermatologic Surgery’ last 21st. Jeuveau is Daewoong Pharmaceutical’s independently developed Botulinum Toxin approved for sale by the U.S. FDA last February and the 3-phase clinical studies (EV-001, EV-002) have been conducted twice for 654 subjects with Glabellar lines in the U.S.  The studies injected the same dosage of Jeuveau and a placebo on patients over 18 years of age with moderate or severe Glabellar lines.  After a certain period of time, the wrinkle correction effect was tested using the double blind method using the 4-point Glabellar Line Scale (GLS). According to the results, the rate of people for whom both the researchers and the subjects themselves reported improvement in wrinkle by two grades or higher among the four grades of GLS 30 days after the injection, was 67.5% and 70.4%, respectively.  The same rate of the placebo group was 1.2% and 1.3%, respectively, and clearly different to prove Jeuveau’s excellence in wrinkle improvement compared to the placebo.  The Jeuveau group’s rate was much higher for 120 days and 150 days later and these findings matched the Global Aesthetic Improvement Scales (GAIS) that evaluated the correction of symptoms after Glabellar line correction.  There are reportedly no cases of serious adverse effects of the drug, so Jeuveau’s safety has also been proven. “Publication on an SCI-level journal has proven Jeuveau’s safety and efficacy once again and Jeuveau would be the standard of Botulinum Toxin products in the future,” said Professor Kenneth Beer, University of Miami, the head researcher of the 3-phase clinic studies and the primary author of the published thesis. “As Jeuveau’s efficacy and safety have been proven by a global clinical study and published on an authoritative international journal, we have been able to announce the excellence of Jeuveau globally,” said Director Seungsoo Park of Daewoong Pharmaceutical’s Nabota Division.  “We will continue to solidify our position as a global brand through various opportunities.” Jeuveau will be released in the U.S. market this spring.  In Europe, EMA’s deliberation for approval is proceeding smoothly and the outline of approval would be ready during the first half of this year. #  #  # [Photo 1] Number of researchers and subjects who reported wrinkle correction by 2 grades or more on the GLS test 30 days after the EV-001 and EV-002 clinical studies (excerpted from the thesis published on Dermatologic Surgery). [Photo 2] GAIS results of researchers and subjects 2, 7, 14, 30, 90, 120, and 150 days after EV-001 (excerpted from the thesis published on Dermatologic Surgery). [Photo 3] GAIS results of researchers and subjects 2, 7, 14, 30, 90, 120, and 150 days after EV-002 (excerpted from the thesis published on Dermatologic Surgery).

The release as fetched from its publisher. daewoong.co.kr ↗