November 2012 | Volume 11 | Issue 11 | Features | 1379 | Copyright © November 2012
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department
may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In
addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval.
FDA Approves Sorilux
Stiefel has announced that the FDA has approved a supplemental
New Drug Application (sNDA) for Sorilux (calcipotriene)
Foam, 0.005%. The sNDA expands the indication for Sorilux
Foam to include the topical treatment of plaque psoriasis of
the scalp in patients 18 years and older.
This approval was based on a multicenter, randomized, double-
blind, vehicle-controlled pivotal phase 3b study of patients
with moderate scalp and body psoriasis. The most common
side effects of Sorilux Foam were redness and pain of the
treated skin areas. The incidence of these adverse reactions
was similar between the body and the scalp.
Sorilux Foam carries a number of warnings, including that
it causes hypercalcemia, it is flammable, and that patients
should avoid excessive exposure of the treated skin to natural
or artificial sunlight (including tanning booths and sunlamps).
FDA Warns Lancôme About Wrinkle Cream Claims
The FDA has posted a letter on its Web site concerning
Lancôme USA's claims that Lancôme's wrinkle and skin
creams "boost the activity of genes and stimulate the production
of youth proteins" and "improve the condition around the
stem cells and stimulate cell regeneration." Lancôme's claims
are found on its own Web site.
The FDA, in its letter, warns Lancôme that such claims "indicate
that these products are intended to affect the structure or
any function of the human body, rendering them drugs under
the Act," referring to the Federal Food, Drug, and Cosmetic
Act. The letter continues, "The marketing of these products
with these claims evidencing these intended uses violates
the Act," because the products were never approved as new
drugs by the FDA.
Some of the Lancôme beauty products that the FDA says violate
the act include: Génifique Youth Activating Concentrate,
Génefique Eye Youth Activating Eye Concentrate, Génefique
Cream Serum Youth Activating Cream Serum, Génifique Repair
Youth Activating Night Cream, Absolue Precious Cells
Advanced Regenerating and Reconstructing Cream SPF 15
Sunscreen, Absolue Eye Precious Cells Advanced Regenerating
and Reconstructing Eye Cream, Absolue Night Precious Cells Advanced Regenerating and Reconstructing Night Cream, and
Rénergie Microlift Eye R.A.R.E. Intense Repositioning Eye Lifter.
Methylprednisolone Aceponate 0.1% and Nickel
The results of a pilot single-blind trial presented at the 21st
Congress of the European Academy of Dermatology and Venerology
(EADV) in Prague leads researchers to conclude that
methylprednisolone aceponate 0.1% (MPA; Advantan®) provides
a fast pruritus relief after first ointment application. In 5 of
10 volunteers, MPA treatment reduced pruritus (measured by a
visual analog scale) by 30% in the first 5 hours posttreatment.
In the independent study, Professor Dr. Ana Giménez-Arnau,
Department of Dermatology, Hospital del Mar, Barcelona,
Spain, and her colleagues assessed pruritus behavior when
volunteers sensitized to nickel sulfate were treated topically
with Advantan®. Pruritus was reduced by 7.1%, 15.3%, 34.3%,
26.7%, and 26.5% at 2, 4, 6, 12, and 24 hours after first use.
Advantan® is a well-established, nonhalogenated diester
corticosteroid indicated for treatment of all stages of atopic
dermatitis (AD). It provides rapid and efficacious relief of signs
and symptoms of AD with low incidences of systemic side effects
in both adults and children. MPA belongs to the latest
class of topical corticosteroids. The substance shows only
limited systemic absorption and a quick inactivation of the
molecule in the systemic circulation. Advantan® is available
in 5 different formulations—fatty ointment, ointment, cream,
milk, and a scalp solution—and is currently marketed in more
than 80 countries worldwide.
Novartis and AIN457 (secukinumab)
Novartis has announced new phase 2 data showing AIN457
(secukinumab) may significantly improve moderate to severe
plaque psoriasis on the hands, feet, and nails when used every
week for the first month of treatment, compared with placebo.
Additional analysis on patients with moderate to severe
plaque psoriasis also showed that AIN457 may successfully
improve quality of life by week 12 in the study.
The new data come out of a double-blind, parallel group, placebo-
controlled phase 2 study involving 404 patients, which
met its primary end point of PASI 75 (Psoriasis Area and Severity
Index) responses at week 12. The study was designed