|Name/Company||Approval Dates and Comments|
Ivermectin 0.5% lotion
Sanofi Pasteur U.S.
The US FDA approved this broad-spectrum antiparasitic agent in February 2012 for the topical treatment of head lice in patients ≥6 months of age. Treatment eradicates most infestations with a single 10-minute application and without nit combing. In clinical trials, <1% of patients experienced adverse events, such as conjunctivitis, ocular hyperemia, eye irritation, dandruff, xerosis, and burning sensation of the skin.
Health Canada approved this human monoclonal antibody in February 2012 for the treatment of metastatic melanoma. Administered intravenously, the drug blocks a T-lymphocyte antigen (CTLA-4), altering the body’s ability to fight off cancerous cells and allowing the immune system to recognize, target, and attack cells in melanoma tumors.
The European Commission approved this oral, small molecule, kinase inhibitor in February 2012 for the treatment of adult patients with BRAFV600 mutation-positive unresectable or metastatic melanoma. This BRAF enzyme inhibitor was approved with a companion diagnostic (cobas® 4800 BRAF V600 Mutation Test) that determines a patient’s eligibility for treatment.
Cellulite removal laser device
The US FDA granted 510(k) clearance for commercial distribution to this novel aesthetic laser device in January 2012 for the long-term reduction of cellulite. This anti-cellulite system utilizes laser fiber and thermal technologies to reduce fat deposits, release areas of skin depression, and increase elasticity and skin thickness. The surgical procedure is minimally invasive (though insertion of a small cannula under the skin), performed under local anesthesia, and completed in one treatment session.
Phase 2 data for a promising new non-surgical injectable treatment for the reduction of submental (under the chin) fat were presented in March 2012 at the American Academy of Dermatology’s 70th Annual Meeting in San Diego, CA. The results were from phase 2B and long-term follow-up clinical trials on ATX-101 (KYTHERA Biopharmaceuticals, Inc.), an investigational drug that causes localized adipocytolysis.1,2 ATX-101 is a proprietary, non-animal derived form of deoxycholate and is being evaluated as a pharmacologic treatment for the reduction of submental fat (SMF). The phase 2B trial was a double-blind, randomized, placebo-controlled study of 129 subjects with moderate or severe SMF. Subjects received injections of one of two ATX-101 doses (1 mg/cm2 or 2 mg/cm2) or placebo, administered monthly for up to 5 months into the SMF area. ATX-101 at the 2 mg/cm2 dose demonstrated a statistically significant clinical benefit compared with placebo in the reduction of SMF as assessed by three efficacy measures: a validated clinician scale, patient reported outcome scale, and MRI measuring SMF volume and thickness. Adverse events were generally mild, the most common included swelling, pain, numbness, bruising, and induration. No systemic adverse events were observed. Additionally, 2-year results from a long-term follow-up study of subjects enrolled in earlier phase 2A trials demonstrated that >90% of subjects who responded to ATX-101 treatment sustained aesthetic correction as measured by the validated clinician scale.
1. Reduction of submental fat with ATX-101: Results from a phase 2B study using investigator, subject, and magnetic resonance imaging assessments (Poster#: 4787).