New Approvals, Indications Highlight Recent FDA Actions in Dermatology

Though 2015 has been a slow year for new FDA approvals, with only a handful of new agents approved through July, a wave of recent activity by the agency saw the approvals of new agents and expanded indications for others.

In October, the FDA approved LEO Pharma’s Enstilar Foam for the topical treatment of plaque psoriasis in adults 18 years of age and older. Enstilar is a once-daily, alcohol free foam formulation in a pressurized spray can that allows application across large body areas of plaque psoriasis. In the pivotal Phase 3 clinical trial, more than half of patients treated with Enstilar were “Clear” or “Almost Clear” by week four as assessed by the Investigator Global Assessment (IGA) score of disease severity. Additionally, more than half of patients treated with Enstilar achieved a 75 percent improvement in Psoriasis Area and Severity Index (PASI) score from baseline. Adverse reactions were reported in less than one percent of patients treated with Enstilar and included application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and exacerbation of psoriasis.

The FDA also in October approved a new melanoma drug offering a brand new approach for advanced melanoma. Amgen’s Imlygic (talimogene laherparepvec), a genetically modified oncolytic viral therapy, was approved for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Imlygic is the first oncolytic viral therapy approved by the FDA based on therapeutic benefit demonstrated in a pivotal study. Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce the immunostimulatory protein granulocyte-macrophage colony-stimulating factor (GM-CSF). Imlygic causes cell lysis, which ruptures tumors, releasing tumor-derived antigens, which along with GM-CSF, may promote an anti-tumor immune response. However, the exact mechanism of action is unknown. Additionally, Amgen noted that Imlygic has not been shown to improve overall survival or have an effect on visceral metastases. (For more on Imlygic and its impact on the melanoma treatment field, read Dr. Jonathan Wolfe’s Oncoloy Watch article on page 37.)

Elsewhere in the realm of melanoma treatments, the FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab) 10 mg/kg for the adjuvant treatment of fully resected Stage III melanoma (lymph node >1 mm), the first and only FDA-approved immune checkpoint inhibitor with the indication. The approval was based on clinical data from a pivotal Phase 3 trial demonstrating that Yervoy 10mg/kg significantly improved recurrence-free survival (RFS) vs. placebo in this setting, with a 25 percent reduction in the risk of recurrence or death. The median RFS was 26 months for Yervoy vs. 17 months for placebo.

BELMONT Study Results Highlight Duration of Investigational Botulinum Toxin Injectable Agent

RT002, an investigational injectable botulinum toxin from Revance Therapeutics, may offer results lasting up to six months, according to a new study. The company reported 24-week results from its multi-center BELMONT Phase 2 study comparing the safety, efficacy, and duration of effect of three doses of RT002 against placebo and BOTOX Cosmetic/VISTABEL®. The topline interim data showed that RT002 achieved its primary efficacy measurement for all three doses at four weeks. The study also demonstrated six-month median duration of effect based upon at least 1-point improvement in glabellar lines at maximum frown on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) scale for patients treated with RT002. Across all cohorts, RT002 appeared to be generally safe and well-tolerated, with only generally mild, localized, and transient adverse events. No participants experienced ptosis, and there were no serious adverse events or evidence of any systemic exposure at any of the three doses evaluated.

New Financial Resource for Dermatologists

Guardian Publishing released Wealth Protection Planning for Dermatologists, the newest book in their series of financial resources for physicians. Wealth Protection Planning is co-authored by David Goldberg, MD, dermatologist, clinical professor, and attorney, along with Guardian principals David Mandell, JD, MBA, Jason O’Dell, MS, CWM, and Carole Foos, CPA, who author Practical Dermatology®’s Financial Planner column.

The book features four concise lessons on practice structure, tax reduction, asset protection, and wealth building—topics that can have a significant impact on a dermatologist’s long-term financial well-being.

“The purpose of this book is to arm you with information,” writes Dr. Goldberg in the book’s introduction. “Each section includes an introductory challenge, followed by lessons in how to handle the issues. The issues and lessons include information on how to protect your assets, reduce your tax liability and plan for retirement while growing your practice.”

As a special offer for Practical Dermatology® readers, visit guardpub.com/product/wppd/ and use promotional code PRDERM to request or download your free copy of Wealth Protection Planning for Dermatologists, available in hard copy and ebook formats for Kindle or iPad.

Agents for Melanoma Among Prix Galien USA 2015 Award Recipients

The Prix Galien USA 2015 Awards have been bestowed on Imbruvica® (ibrutinib) for best pharmaceutical agent, Opdivo® (nivolumab) and Keytruda® (pembrolizumab) for best biotechnology product, and the T2Candida Panel for best medical technology. The 2015 Prix Galien USA Award for Best Pharmaceutical Agent was awarded to Janssen Biotech & Pharmacyclics’ IMBRUVICA® (ibrutinib), a first-in-class, oral, once-daily therapy for the treatment of patients with chronic lymphocytic leukemia and mantle cell lymphoma. The 2015 Pro Bono Humanum Award, which recognizes ground-breaking efforts in improving human health, was presented to Mary-Claire King, PhD, Professor of Genome Sciences and Medical Genetics at the University of Washington and renowned geneticist. Professor King is the first woman recipient of the award.

Promius Reports Promising Phase 3 Results for Psoriasis Spray

Findings from two Phase 3 studies for Promius Pharma’s investigational psoriasis drug DFD-01, a novel formulation of betamethasone dipropionate, 0.05% available in an emollient spray, show it achieved the primary endpoint at day 15. The primary endpoint was the proportion of patients achieving treatment success at day 15 for both studies. In addition, both studies met a secondary endpoint of treatment success at day 29. Treatment success was analyzed using Cochran–Mantel–Haenszel.

More than 500 adult patients with moderate psoriasis were enrolled in both studies and randomized to receive DFD-01, augmented betamethasone dipropionate lotion or vehicle. Mean BSA was between 13 percent and 14 percent for all groups, and there were no notable differences between groups or studies. DFD-01 improved signs of erythema, scaling, and elevation in target lesions. Both DFD-01 and its vehicle were well tolerated. According to the investigators, the majority of adverse events (AEs) were mild to moderate with no notable increases in adverse events between two and four weeks of treatment. n