FDA actions, Xeljanz study top August dermatology reads

Study results focusing on Xeljanz as a possibly effective treatment for vitiligo continued to be widely read during August on Healio.com/Dermatology.

Other top read articles included FDA approval of a clinical trial of a treatment for androgenic alopecia and the agency issuing a safety alert regarding reports of severe allergic reactions and herpes zoster associated with the use of Picato gel:

Xeljanz might be effective as vitiligo treatment

Xeljanz (tofacitinib citrate, Pfizer) was effective as treatment in a patient with vitiligo, according to recently published study results.

Brett A. King

Brett A. King, MD, PhD, and colleague Brittany G. Craiglow, MD, reported on a woman in her 50s who had widespread and progressive vitiligo for approximately 1 year. Read more

Kerastem receives FDA approval for clinical trial of alopecia treatment

The FDA Center for Biologics Evaluation and Research Office of Cellular, Tissue and Gene Therapies has given conditional approval to Kerastem Technologies to conduct a clinical trial to study the safety and feasibility of its treatment of androgenic alopecia, according to a press release.

The phase 2 STYLE study will be a follow-up trial to initial clinical data from Europe and Japan that was used as the basis for the FDA investigational device exemption submission, according to the release. The controlled trial will include 70 patients and is expected begin enrollment in late 2015 at eight centers throughout the United States, according to the release. Read more

FDA grants orphan drug status to Humira for treatment of hidradenitis suppurativa

AbbVie announced that the FDA has granted orphan drug designation to Humira for treating moderate-to-severe hidradenitis suppurativa.

The supplemental biologic license application by Abbvie seeking the agency’s approval for the use of Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (Hurley Stage II and Hurley Stage III disease) is being reviewed by the FDA, according to a press release. Read more

Rosacea severity linked to systemic comorbidities

The rate of systemic comorbidities for patients with rosacea was associated with rosacea severity, according to recent study results.
Barbara M. Rainer, MD, and colleagues evaluated 130 participants in the case-control study: 65 with rosacea and 65 without. They analyzed the correlation between systemic comorbidities and severity of rosacea in patients when compared to controls. Read more

FDA warns of severe adverse reactions with Picato gel, requires label change

The FDA has issued a safety alert regarding reports of severe allergic reactions and herpes zoster associated with the use of Picato gel.

Picato gel (ingenol mebutate, LEO Pharma) is used to treat actinic keratosis. Throat tightness, difficulty breathing, feeling faint or swelling of the lips or tongue were allergic reactions reported by the FDA in a MedWatch safety alert. Read more