March 2015 | Volume 14 | Issue 3 | Features | 320 | Copyright © March 2015
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.
Promius Pharma Expands the Reach of the Promius
Promise With a New App for Isotretinoin Patients
According to an FDA review of Year 5 of the iPLEDGE™ program
(3/1/10 – 2/28/11), over 400,000 attempts to fill isotretinoin prescriptions were denied due to failures to meet iPLEDGE™ requirements. To help support patients, Promius Pharma, marketers
of Zenatane™ (Isotretinoin Capsules USP), a generic form of isotretinoin, has created the Promius Promise App designed
to help educate and guide patients through the various treatment requirements.
The Promius Promise App can be downloaded free of charge by anyone who has received a prescription for Zenatane™ through the Promius Promise program. It provides answers to frequently asked questions and makes it easy for the patient to find important
information, which may make sticking with treatment requirements easier. The App, which acknowledges that there are many steps involved in the treatment process, and outlines them with an easy-to-follow roadmap. The idea for the App came from market research that suggested it may be especially beneficial for young adults and teenagers. It can serve as a tool for parents as well, who may want easy access to Promius Promise information and phone numbers in the event a question arises, so they can support the isotretinoin patient in their life. Providers can also use the App to access the new secure web portal if they desire current information on prescriptions of Zenatane™ for their patients.
Novartis Announces FDA approval for First IL-17A
Novartis announced the FDA has approved Cosentyx™ (secukinumab)
for the treatment of moderate-to-severe plaque psoriasis in
adult patients who are candidates for systemic therapy (a drug that
is absorbed into the bloodstream and distributed to all parts of
the body) or phototherapy (light therapy). Cosentyx is the first
approved psoriasis medication to selectively bind to IL-17A
and inhibit interaction with the IL-17 receptor. The approval
is based on the efficacy and safety outcomes from 10 Phase
II and Phase III studies, including over 3,990 adult patients with
moderate-to-severe plaque psoriasis, which demonstrated that
Cosentyx resulted in clear or almost clear skin in the majority of
patients and had an acceptable safety profile.
Valeant Introduces AMBI Even & Clear CC+ Even
Tone Environmental Shield
Valeant introduced the NEW AMBI® EVEN & CLEAR CC+ CREAM
Even Tone Environmental Shield – the first color product in the
AMBI® Skincare Line. Specially formulated to match the rich
tones of women of color, this CC+ Cream contains argan oil,
shea butter, and antioxidants to moisturize the skin.
AMBI® CC+ Cream provides broad-spectrum SPF 30 sunscreen
protection from UV sun rays that can accelerate the formation
of fine lines and wrinkles. This sunscreen is formulated not to
leave the skin looking ashy or gray.
Galderma Receives FDA Approval of Treatment
Galderma Laboratories, L.P. has announced that the FDA has approved
Galderma’s Soolantra® (ivermectin) Cream, 1% for the
once-daily topical treatment of inflammatory lesions of rosacea.
The approval of Soolantra Cream was based on two pivotal
phase 3, multicenter, randomized, doubleblind, 12-week,
vehicle-controlled, parallel-group studies where Soolantra
Cream met each of its coprimary efficacy endpoints. The onset
of treatment effect was observed as early as week two
with continuous improvement. In long-term extensions to
the 12-week studies, Soolantra Cream was also safe and
well-tolerated for an additional 40 weeks. Some study subjects
experienced skin burning sensation and skin irritation
while using Soolantra Cream.
Galderma also reports that in a separate head to head study
with metronidazole 0.75% cream Soolantra Cream was shown
to be more efficacious from as early as week three onwards.
FDA Approves Generic Version of Valcyte
The FDA has approved Dr. Reddy’s and Endo’s AB-rated generic
versions of Roche’s Valcyte (valganciclovir) 450 mg
tablets. Valcyte is indicated for adult patients in the treatment
of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency
syndrome and prevention of CMV disease in
kidney, heart, or kidney; pancreas transplant patients at high