News & Trends
Avon Products, Inc. has become the second cosmetic company in as many months to be warned by the FDA about making claims on its website that describe the company’s products as drugs. As with the Génifique/Lancôme USA/L’Oreal warning in September 2012, the FDA has cited Avon for making claims that make certain products drugs under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act [21 U.S.C. § 321(g)(1)(C)].
Avon products cited in the FDA warning include a number of items from the Anew line and the Solutions Liquid Bra Toning Gel. As stated in the letter, the claims Avon makes on its website about these products make it appear as though the products “are intended to affect the structure or any function of the human body, rendering them drugs under the Act.” As a result, the marketing of the products with such claims violates the Act. Some examples of these claims in the FDA letter include “The at-home answer to wrinkle-filling injections. Start rebuilding collagen in just 48 hours” and “Formulated to boost shock-absorbing proteins to help strengthen skin’s support layers.” These claims, in particular, are made about the Anew Clinical Advanced Wrinkle Corrector, according to the FDA letter.
As with the warning issued to Lancôme USA in September, the FDA has given Avon 15 working days after receipt of the letter to demonstrate that steps are being taken to correct the violations. The company also has the opportunity to contest the FDA warning by including reasoning and any supporting information for why the claims are not a violation.
A combination approach with chemotherapy and immunotherapy has resulted in a high response rate from patients with metastatic melanoma.
Researchers from the Moffitt Cancer Center in Tampa, FL treated 19 patients with a combination of non-myeloablative chemotherapy and immunotherapy of adoptive cell transfer (ACT) with tumor-infiltrating lymphocytes (TIL), followed by interleukin-2. According to the results of the study in the Journal of Immunotherapy (JI), an overall response rate (partial and complete responses) of 26% was achieved by intention-to-treat, with a median follow-up of 10 months. Among the 13 treated patients, there were two complete responses and three partial responses (38% response rate among treated patients), along with four patients with stable disease ranging from 2+ to 24+ months. A majority of the patients with stable disease (three out of four) have had disease control without additional therapy, including one at 24+ months, according to the results in JI.
According to Amod Sarnaik, MD, assistant member of the Cutaneous Oncology Department at Moffitt, “Our purpose was to demonstrate the feasibility of performing TIL growth and the efficacy of ACT TIL therapy using techniques developed at the National Cancer Institute. Combining chemotherapy with adoptive cell transfer and high dose IL-2 resulted in a 38% objective response rate in patients with metastatic melanoma.”
A second-generation ACT TIL trial is currently enrolling patients at Moffitt. For more information on the new trial, please visit http://1.usa.gov/UNGUw8.
Shari PT, Kuhn L, Ellwanger S, et al. Efficacy of adoptive cell transfer of tumor-infiltrating lymphocytes after lymphopenia induction for metastatic melanoma. J Immunother. 2012 Oct;35(8):615-620.
Taclonex Topical Suspension Now Approved for the Treatment of Body Plaque Psoriasis
LEO Pharma Inc., a wholly owned US subsidiary of LEO Pharma A/S, recently announced that the FDA approved Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064% for the treatment of body plaque psoriasis. Taclonex Topical Suspension is a first-line single treatment now indicated for both scalp and body plaque psoriasis for up to 8 weeks.
Taclonex Topical Suspension is a once-daily, steroid-containing topical treatment that combines the strength and benefits of two active ingredients — a vitamin D analog (calcipotriene) and a corticosteroid (betamethasone dipropionate). Taclonex Topical Suspension requires only one prescription for both scalp and body treatment of plaque psoriasis. Patients using Taclonex Topical Suspension may also be eligible to participate in LEO Quality Care,TM a patient support program, according to the company.
“A once-daily application makes Taclonex Topical Suspension an effective, first-line choice of treatment for a significant number of psoriasis patients, with positive clinical results seen in a recent eight-week study,” said Dr. Alan Menter, founder of the International Psoriasis Foundation, in a company-issued release. “In addition to its prior approval for use on the scalp, it has been shown to be safe and effective for use on the body.”
In two Phase III clinical studies of more than 1,600 patients with psoriasis on the scalp, and one phase III clinical study of more than 1,100 patients with psoriasis on the body, a higher percentage of patients treated with Taclonex Topical Suspension achieved controlled disease than either monotherapies or vehicle used alone, according to the company. In clinical trials, the most common adverse reactions that occurred in >1% of patients treated with Taclonex Topical Suspension and at a rate higher than in patients treated with vehicle were folliculitis and burning sensation of the skin.
“We are pleased to introduce Taclonex Topical Suspension as part of our ongoing commitment to helping people achieve healthy skin,” said John Koconis, president and chief executive officer of LEO Pharma Inc. “This most recent FDA approval offers a new, single treatment option for patients suffering from plaque psoriasis on both scalp and body locations, and we look forward to continuously driving patient-centered innovation in the field of dermatology in the years to come.”
Miramar Labs has released data from a 2-year study of the miraDry procedure for the treatment of primary axillary hyperhidrosis, with results demonstrating that the procedure is significantly effective and leads to an improvement in quality of life for patients.
All of the participants in the 24-month study achieved low ratings on the Hyperhidrosis Disease Severity Scale (HDSS), according to published reports; the participants reported HDSS scores of 1 or 2, which indicate that underarm sweating no longer substantially impacts their daily lives. In addition, the Dermatology Life Quality Index scores from patients went from an average baseline score of 11.8 to 1.3, which indicates long-term stability.
“We are delighted to see consecutive studies that support the efficacy, safety and improved quality of life in patients who have had the miraDry procedure,” explains Darrell J. Zoromski, president and CEO of Miramar Labs. “Given that other primary therapies currently available provide only short-term relief or are ineffective, we are seeing a growing demand for a lasting treatment option to address this embarrassing condition.”
Independent Role for IL-36 May Be Important in Development of Novel Psoriasis Treatments
A number of interleukin (IL) pathways have been implicated in the development of psoriasis, including IL-17, IL-22 and IL-23. Another group, IL-36α, IL-36β and IL-36γ, are novel members of the IL-1 cytokine family that all bind to the IL-36 receptor, a process that initiates a longer cascade of cellular events related to the development of psoriasis. The link between psoriasis and IL-36 continues to be demonstrated in research studies. A recent article in the Journal of Clinical Investigation (JCI) discusses a novel IL-1-independent role for IL-36 in control of the IL-23/IL-17/IL-22 pathway and the development of psoriasis.
Researchers from the United States, Belgium and Switzerland induced psoriasis in mice with imiquimod and studied them in comparison to wild-type mice. IL-36R-deficient mice were protected from imiquimod-induced expansion of dermal IL-17-producing γδ T cells and psoriasiform dermatitis, and IL-36R antagonist-deficient mice showed exacerbated pathology. Mice lacking IL-23, IL-17 or IL-22 were less well protected from disease than IL-36R-deficient mice, which, according to the study in JCI, indicate “an additional distinct activity of IL-36 beyond induction of the pathological IL-23 axis.”
Taken together, these results “suggest that the balance of endogenous IL-36R ligands and IL-36R antagonist plays a pivotal role in IMQ-induced skin disease,” according to the researchers. In addition, in conjunction with recent reports showing that some patients with pustular psoriasis have mutations in the IL36RN gene, the results of the study “suggest that blocking IL-36R signaling might be a promising approach for the specific treatment of psoriasis.”
Tortola L, Rosenwald E, Abel B, et al. Psoriasiform dermatitis is driven by IL-36-mediated DC-keratinocyte crosstalk. J Clin Invest. 2012 Oct 15. pii: 63451. doi: 10.1172/JCI63451. [Epub ahead of print].
Novel Understanding of Atopic Dermatitis on Cellular Level May Lead to New Treatment Options
Blocking a part of the cellular process that causes itching in the skin of patients with atopic dermatitis (AD) may allow for the ability to control the desire to scratch, and therefore reduce the intensity of AD flares, a new study reveals.
An international team of researchers from the United States, China and Switzerland based their study on the knowledge that scratching triggers flares for AD patients. The team found that scratching of human skin and tape stripping of mouse skin caused neutrophil influx; in mice, this influx was largely dependent on the generation of leukotriene B4 (LTB4) by neutrophils and their expression of the LTB4 receptor BLT1, according to the results of the study in Immunity. Allergic skin inflammation in response to the epicutaneous (EC) application of ovalbumin to tape-stripped skin was severely impaired in Ltb4r1−/− mice and required expression of BLT1 on both T cells and non-T cells, while “cotransfer of wild-type (WT) neutrophils, but not neutrophils deficient in BLT1 or the LTB4-synthesizing enzyme LTA4H, restored the ability of WT CD4+ effector T cells to transfer allergic skin inflammation to Ltb4r1−/− recipients.”
The researchers also found that pharmacological blockade of LTB4 synthesis inhibited allergic skin inflammation elicited by cutaneous antigen challenge in previously EC-sensitized mice.
According to Dr. Michiko K. Oyoshi, of the Division of Immunology at Boston Children’s Hospital in MA and first author on the paper in Immunity, the study findings “suggest that neutrophils play a key role in allergic skin inflammation and that blockade of leukotriene B4 and its receptor might provide a new therapy for eczema.”
Oyoshi MK, He R, Li Y, et al. Leukotriene b4-driven neutrophil recruitment to the skin is essential for allergic skin inflammation. Immunity. 2012 Oct 19;37(4):747-58. doi: 10.1016/j.immuni.2012.06.018. Epub 2012 Oct 11.
Active Ingredient in Glaucoma Drug is Also Effective for Hair Loss
Lead researcher Valerie Randall, a professor at the University of Bradford who is an expert on the regulation of hair growth, and colleagues examined Lumigan, which is used to treat glaucoma. The researchers found that bimatoprost, the active ingredient in Lumigan, stimulated hair growth in both mouse and human models. When they tested the active ingredient on a human organ culture model system, they found living scalp follicles treated with bimatoprost grew a third more hair than control samples in 9 days.
The researchers also determined how the drug worked. Because bimatoprost boosted growth in isolated scalp hair follicles, it had to be working directly on the hair follicle cells, according to the team; they found specific receptors that bind bimatoprost and a related natural signalling molecule, prostamide F2 alpha, within the hair follicle. When these receptors were blocked, the drug was no longer effective, the team explains.
“This is the first time this prostamide signalling system has been identified in the hair follicle,” Professor Randall explains. “Male pattern baldness and alopecia areata have specific causes which aren’t connected to the receptors that bimatoprost works on. This means that the drug should still work in people suffering from these types of hair loss.”
In order to determine that the active ingredient in Lumigan would work as well for patients as it did in the lab, the researchers needed to see if these receptors were present not only in the laboratory-grown hair follicles but in follicles taken directly from human scalp tissue.
“We tested samples of scalp tissue taken following surgery and found they had the same receptors which respond to bimatoprost,” says Professor Randall. “This means that, so long as the drug can be applied in such a way that it can reach the follicle, it should stimulate hair growth in patients.”