| Name/Company | Approval Dates and Comments |
| Oxymetazoline hydrochloride 1% cream Rhofade™ Allergan plc |
The US FDA approved oxymetazoline hydrochloride 1% cream in January 2017 for the topical treatment of persistent facial erythema (redness) associated with rosacea in adults. Approval was based on two clinical trials that demonstrated once-daily application of oxymetazoline hydrochloride 1% cream (Rhofade™) reduced persistent facial erythema associated with rosacea through 12 hours. The primary efficacy endpoint was at Day 29 and defined as the proportion of patients with at least a 2-grade reduction in erythema from baseline (pre-dose on day 1) on both the clinician erythema assessment and subject self-assessment measured at hours 3, 6, 9 and 12 vs. vehicle. Rhofade™ was proven to be more efficacious compared with vehicle in reducing persistent facial erythema associated with rosacea in adults. |
| Brodalumab for SC injection Siliq™ Valeant Pharmaceuticals |
In February 2017, the FDA approved brodalumab, a monoclonal antibody that targets the interleukin (IL)-17 receptor, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. Administered as a subcutaneous injection, brodalumab binds to IL-17, inhibiting several pro-inflammatory cytokines from the IL-17 family, which are thought to contribute to the pathophysiology associated with psoriasis. Brodalumab’s safety and efficacy were established in three randomized, placebo-controlled clinical trials involving a total of 4,373 adult participants with moderate-to-severe plaque psoriasis who were candidates for systemic therapy or phototherapy. More patients treated with brodalumab compared to placebo had skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin. Suicidal ideation and behavior, including completed suicides, have occurred in patients treated with brodalumab during clinical trials. Siliq™ users with a history of suicidality or depression had an increased incidence of suicidal ideation and behavior compared to patients without this history. A causal association between treatment with brodalumab and increased risk of suicidal ideation and behavior has not been established. Because of the observed risk of suicidal ideation and behavior, the labeling for Siliq™ includes a Boxed Warning and the drug is only available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Siliq™ REMS Program. |
| Device News | |
| Cryolipolysis for upper arm fat reduction CoolAdvantage™ Petite applicator for CoolSculpting® Zeltiq® Aesthetics, Inc. |
In January 2017, the FDA granted clearance to CoolSculpting® for fat reduction of the upper arms with the CoolAdvantage™ Petite applicator. The CoolAdvantage™ Petite treatment comes with two interchangeable contours designed to uniquely treat the upper arm area in 35 minutes. CoolSculpting® is now FDA-cleared for the reduction of localized subcutaneous fat in the submental area, thigh, abdomen, flank, bra and back fat area, underneath the buttocks, and the upper arm. |
| Wound healing device WoundShiel™ NanoVibronix |
In January 2017, the FDA granted clearance to CoolSculpting® for fat reduction of the upper arms with the CoolAdvantage™ Petite applicator. The CoolAdvantage™ Petite treatment comes with two interchangeable contours designed to uniquely treat the upper arm area in 35 minutes. CoolSculpting® is now FDA-cleared for the reduction of localized subcutaneous fat in the submental area, thigh, abdomen, flank, bra and back fat area, underneath the buttocks, and the upper arm. |
