drugset / Press release

The clinical findings of Botulinum Toxin manufactured by Daewoong have been published on international journal regarding the comparison with Botox

2019-04-12 · Daewoong Pharmaceutical Co. LTD. · original daewoong.co.kr ↗

The clinical findings of Botulinum Toxin manufactured by Daewoong have been published on international journal regarding the comparison with Botox - The 3-phase clinical results from Europe and Canada published on April issue of Aesthetic Surgery Journal 4, an international journal equivalent to SCI. - Proven non-inferiority compared to Botox in terms of Glabella frown line correction and safety. Daewoong Pharmaceutical (CEO Sengho Jeon) announced on the 12th that the 3-phase clinical results of its botulinum toxin (known as JEUVEAU in the U.S.) from Europe and Canada were published on Aesthetic Surgery Journal on the 5th. Botulinum Toxin manufactured by Daewoong Pharmaceutical obtained the approval from the U.S. FDA for Glabella frown line last February.  In Korea, it was approved by KFDA  for Glabella frown line improvement, eye wrinkle  improvement, and post-stroke upper limbs spasticity . The new study is the 3-phase study (EVB-003) executed in Europe and Canada and it is a non-inferiority clinical study that directly compares JEUVEAU with Botox of Allergan.  For 540 subjects who were 18 years old or older and in Grades 2 and 3 of GLS (Glabellar Line Scale, 0=No wrinkle, 1=Minor, 2=Moderate, 3=Severe) were given 1 injection of equal amounts of JEUVEAU and Botox to check the wrinkle correction results with the researcher after a certain length of time using the double-blind method. The first effectiveness assessment took place 30 days after injection.  As a result, 87.2% of the JEUVEAU group and 82.8% of the Botox group showed improvement of Glabellar Line to GLS 0 or 1.  This has proven JEUVEAU’s non-inferior effect on improvement in wrinkle in comparison to Botox.  Also, GAIS (Global Aesthetic Improvement Scales) was used to assess the Glabellar line correction up to 150 days after the injection and the number of subjects in the JEUVEAU group who reported correction of Glabellar lines was greater than that of the Botox group. “The publication of a clinical study that proved the non-inferiority to Botox on an international journal is a very significant outcome,” said Director Seongsoo Park of Daewoong Pharmaceutical’s Nabota Division.  “JEUVEAU is the first 900 kDa product entering the U.S. market after Allergan’s Botox and JEUVEAU’s superior effectiveness and safety have been proven clinically and expected to attract the practitioners and patients in the U.S.” Goldman Sacks, a global investment firm, and Wall Street Journal, which is one of the three newspapers of the U.S., have analyzed the impact of JEUVEAU on the competition of the U.S. Botulinum Toxin market and reported about the local people’s interests in JEUVEAU. #  #  # [Daewoong Pharmaceutical Image] The 3-phase clinical results of JEUVEAU (Prabotulinumtoxin A, manufactured by Daewoong Pharmaceutical) from Europe and Canada were published on Aesthetic Surgery Journal.

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