Endo Announces FDA's Acceptance of Original Biologics License Application (BLA) for Collagenase Clostridium Histolyticum (CCH) in Patients with Cellulite
"We have confidence in and are excited by the promising results of our CCH for cellulite program, which encompasses the largest U.S. clinical trials for the treatment of cellulite in history1," said
The BLA is supported by the results of the RELEASE*-1 and RELEASE-2 Phase 3 studies, as well as a robust clinical and pre-clinical program.
Cellulite is a localized alteration in the contour of the skin that has been reported in 85 to 98 percent of post-pubertal females and affects women of all races and ethnicities.2,3 The primary cause of the condition is a thickening of the collagen septae that attach the skin to the underlying fascia layers with additional contributing protrusions of subcutaneous fat. The septae tether the skin, which causes the surface dimpling characteristic of cellulite.3,4 Cellulite clinically presents on the buttocks, thighs, lower abdomen and arms.
It is known that cellulite is different from generalized obesity. In generalized obesity, adipocytes undergo hypertrophy and hyperplasia that are not limited to the pelvis, thighs, and abdomen.5 In areas of cellulite, characteristic large, metabolically stable adipocytes have physiologic and biochemical properties that differ from adipose tissue located elsewhere. Weight gain makes cellulite more noticeable, but it may be present even in thin subjects. Genetics may also play a role, since cellulite tends to run in families.
Despite multiple therapeutic approaches for the attempted treatment of patients with cellulite, there are currently no
Forward Looking Statements
This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation, including, but not limited to, the statements by Mr. Campanelli, and other statements regarding
*Randomized EvaLuation of CEllulite Reduction by CollAgenaSE Clostridium Histolyticum (RELEASE)
US National Library of Medicine. ClinicalTrials.gov. National Institutes of Health. Accessed March 19, 2019.
- Avram M. Cellulite: a review of its physiology and treatment,
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- Khan MH et al. Treatment of cellulite: Part I. Pathophysiology. J Am Acad Dermatol. 2010 Mar;62(3):361-70.
- Querleux B et al. Anatomy and physiology of subcutaneous adipose tissue by in vivo MRI and spectroscopy: Relationship with sex and presence of cellulite,
Skin Researchand Technology; 8: 118-124.
- Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: Part I. Pathophysiology. J Am Acad Dermatol 2010;62(3):361-370.
- Zerini I et al. Cellulite treatment: a comprehensive literature review. J Cosmet Dermatol. 2015 Sep 14(3):224-40
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