LAVIV is the first FDA approved cellular therapy to treat the wrinkles of the laugh lines of the smile lines. LAVIV is unlike the facial fillers made of hyaluronic acid or calcium hydroxylapatite. The Miami Institute in
Brickell is the first practice in South Florida to start using this
novel treatment.The cost for LAVIV treatment is between $3,000 and $3,500.
Proprietary Name: LAVIV®
Established (USAN) Name: azficel-T
Indication: LAVIV® is indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.
Product description
The active ingredient in azficel-T is autologous cultured fibroblasts. The fibroblasts are cultured, using standard methodologies, from three 3-mm punch biopsies (dermal and epidermal layers) taken from a patient’s post-auricular area. Fibroblasts, due to their proliferative nature, expand more rapidly in culture than the other dermal cell types present, such as keratinocytes. Fibroblasts represent more than 98% of the final product. Following in vitro expansion, the fibroblasts are harvested and quality control tests are performed. The cell suspension is cryopreserved in protein-free media containing DMSO at a defined cell concentration. When required for clinical use, a dose of cells is thawed, washed, formulated to 1.0–2.0 x 107 cells/ml and shipped to the clinical site at 2-8°C by overnight delivery for use within 24 hours of final formulation. The cells are injected intradermally into the nasolabial folds in three separate doses given four to six weeks apart.
No preclinical studies were conducted with azficel-T.
Approximately 1100 subjects received azficel-T at 110 clinics during the 4-year period when the product was marketed in the US (see section 2 Background above). The applicant states that no serious adverse events were reported during this time. Considering this previous commercial experience in humans, and due to the lack of an appropriate animal model for wrinkles, no preclinical studies using azficel-T were necessary.
Efficacy
The co-primary efficacy endpoints for the two pivotal trials were:
Proportion of subjects with at least a two-point improvement, from baseline to six months post-treatment, in wrinkles in both nasolabial folds, using the Evaluator Wrinkle Severity Assessment, a blinded, live assessment using a 6-point ordinal scale (Lemperle scale).
Proportion of subjects with at least a two-point improvement, from baseline to six months post-treatment, in the Subject Wrinkle Assessment, a global 5-point self-assessment of the lower part of the face.
The co-primary efficacy endpoints for the two pivotal trials were:
Proportion of subjects with at least a two-point improvement, from baseline to six months post-treatment, in wrinkles in both nasolabial folds, using the Evaluator Wrinkle Severity Assessment, a blinded, live assessment using a 6-point ordinal scale (Lemperle scale).
Proportion of subjects with at least a two-point improvement, from baseline to six months post-treatment, in the Subject Wrinkle Assessment, a global 5-point self-assessment of the lower part of the face.
Summary Basis for Regulatory Action, Date: June 20, 2011, BLA/ STN#: 125348/0
