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FDA Actions

Nivolumab Approved in Combination with Ipilimumab

The FDA granted accelerated approval to nivolumab (Opdivo Injection, Bristol-Myers Squibb Company) in combination with ipilimumab for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

In a clinical trial that randomized (2:1) 142 patients to receive nivolumab plus ipilimumab (n=95) or ipilimumab plus placebo (n=47), there was a significant improvement in ORR for combination treatment. The ORR was 60% in the nivolumab plus ipilimumab group (n=72) and 11% in the ipilimumab group (n=37), an improvement in ORR of 49%. Among the 140 patients with BRAF V600 wild-type or mutation-positive melanoma who received at least one dose of nivolumab or ipilimumab, serious adverse reactions (62% vs. 39%), adverse reactions leading to permanent discontinuation (43% vs. 11%) or dose delay (47% vs. 22%), and grade 3 or 4 adverse reactions (69% vs. 43%) all occurred more frequently in patients receiving the combination (n= 94) compared with those receiving single-agent ipilimumab (n=46). Read more at

FDA Approves Juvederm® Ultra XC for Use in Lips

Allergan has received FDA approval to market Juvederm® Ultra XC for injection into the lips and perioral area for lip augmentation in adults over the age of 21. It is the only dermal filler that has proven results lasting up to one year for lip augmentation.

In clinical trials of Juvederm® Ultra XC, the majority of subjects reported improvement in the softness, smoothness, and natural look and feel of their lips through one year. In clinical trials, 79 percent of subjects showed a meaningful improvement in lip fullness three months after treatment. Additionally, more than 78 percent of subjects reported an improvement in their overall satisfaction with the look and feel of their lips at one year after treatment.

ZELTIQ Receives FDA Clearance to Treat Submental Fat With Coolsculpting Procedure

The FDA granted an expanded clearance for ZELTIQ® Aesthetics, Inc.’s Coolsculpting procedure, paving the way for the introduction of the new, CoolMini™ applicator, which is designed to treat smaller pockets of fat, including the submental, or chin fat area. The CoolSculpting® procedure has demonstrated in more than 50 published clinical articles and 4,000 clinical trial patients to non-invasively and consistently reduce unwanted fat and the procedure has been successfully used in over two million treatments to date, according to the company.

The new CoolMini applicator is uniquely designed for small volume areas of fat. The applicator’s size, shape, and curvature is designed to comfortably fit these small, problem areas. Patients may see results as early as three weeks, with the most dramatic results generally observed one to three months following treatment.

The FDA clearance is based on data from a US pivotal clinical trial involving 60 male and female patients, ranging in age from 22 to 65 years. In the trial, patients received one to two treatments in the area under the chin, each six weeks apart resulting in an average of 20 percent fat reduction, which is in line with results achieved with other CoolSculpting applicators. Additionally, no significant adverse events were observed and patients experienced little to no discomfort or downtime.

Over 500 CoolMini treatments have been performed to date as a result of pilot clinical work, clinical trials, and the company’s controlled European launch that commenced in June. The results, achieved in as little as one to two office visits, have been very encouraging with very high patient satisfaction and the same level of efficacy achieved with other CoolSculpting applicators.

Allergan Completes Acquisition of Kybella Maker Kythera

Allergan has successfully completed the acquisition of Kythera Biopharmaceuticals, Inc. Allergan acquired Kythera in an all-cash transaction valued at approximately $2.1 billion.

The acquisition of Kythera adds Kybella® (deoxycholic acid) injection, the first FDA approved non-surgical injection for improvement in the appearance of moderate to severe submental fullness in adults. Kybella is administered by a trained physician who injects the product under a patient’s chin to destroy fat cells, improving the appearance of the patient’s chin area. Up to six treatments may be administered per patient no less than one month apart, and each in-office treatment session lasts approximately twenty minutes.

The acquisition also adds Kythera’s developmental product setipiprant (KYTH-105), a novel compound for the prevention of androgenetic alopecia (AGA), as well as additional early-stage development candidates. Kythera has submitted an Investigational New Drug Application (IND) to the FDA for setipiprant for the treatment of AGA. Allergan plans to conduct a human proof-of-concept study to evaluate the efficacy and safety of setipiprant in male subjects with AGA.

Revance Initiates Phase 3 Trial of Botulinum Toxin Type A Topical Gel for Crow’s Feet

Revance Therapeutics, Inc. has commenced dosing patients in the Phase 3 pivotal study to evaluate the safety and efficacy of its RT001 investigational topical drug product candidate for the treatment of lateral canthal lines, or crow’s feet. The Phase 3 trial will evaluate the safety and efficacy of a single, bilateral administration of RT001 topical gel compared to placebo in patients with moderate to severe crow’s feet. The company plans to release interim results from this Phase 3 study in the first half of 2016.

The Phase 3 trial is a randomized, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of RT001, also referred to as RTT150 (Botulinum Toxin Type A) Topical Gel, for the treatment of moderate to severe lateral canthal lines. A total of up to 450 adult patients will be enrolled at multiple sites in the US and will be randomized 1:1 to a single treatment of either RT001 topical gel or placebo. The product will be applied to lateral canthal lines on both sides of the face using Revance’s proprietary applicator.

The primary efficacy endpoints are composites based upon the Investigator’s Global Assessment of Lateral Canthal Lines (IGA-LCL) assessment and the Patient Severity Assessment (PSA) between baseline and 28 days after treatment. One composite endpoint includes those patients with a 2-point or greater improvement as graded by the investigator’s assessment and the patient’s self-assessment. The other composite endpoint includes those patients who experience a 1-point or greater improvement in the investigator’s and patient’s assessments.

Secukinumab Phase III Data Promising for PSA

Results from the Phase 3 FUTURE 1 study for secukinumab in psoriatic arthritis (PsA) published online in The New England Journal of Medicine (NEJM) show the IL-17a antagonist met the primary endpoint based on a significantly higher percentage of patients who achieved at least an ACR 20 at Week 24 versus placebo. Results showed half of patients (50.0% and 50.5%) in both secukinumab-treated dose groups (150 mg and 75 mg; p<0.001) achieved ACR 20 response compared with only 17.3% of placebo patients. Exploratory analyses showed more secukinumab-treated patients in the 150mg and 75mg dose groups experienced ACR 20 responses by Week 1 versus placebo (p<0.001). Secukinumab was well tolerated in the study, with a safety profile generally consistent with that observed in the psoriasis clinical trial program. Secukinumab is not indicated for PsA.

Novan: SB204 Positive in Phase 2b Trial for Acne Vulgaris

Novan Therapeutics’ topical nitric oxide drug candidate SB204 for the treatment of acne vulgaris demonstrated statistically significant reductions in the percent change of non-inflammatory and inflammatory lesions in a Phase 2b study. The 12-Week study, reported by the company, demonstrated positive findings with all doses of SB204 compared to Vehicle.  SB204 demonstrated excellent cutaneous tolerability with no treatment-related serious adverse events in over 400 dosed subjects to date.  

Based on these results and having completed an End-of-Phase 2 meeting with the FDA, Novan plans to initiate two pivotal Phase 3 trials with SB204 once daily in the first quarter of 2016, targeting enrollment of 1,300 subjects per trial. More study details available at n

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