April 2012 | Volume 11 | Issue 4 | Features | 546 | Copyright © April 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.
National Psoriasis Foundation Releases
The National Psoriasis Foundation has published new guidelines
for the management of plaque psoriasis—the most prevalent
form of the most common autoimmune disease in the country.
The consensus guidelines from the National Psoriasis Foundation Medical Board, adapted from the Canadian Guidelines for
the Management of Plaque Psoriasis to reflect U.S. practice patterns, aim to clarify when to use oral and biologic medications
for people whose psoriasis requires more than topical treatment.
A table summarizing the latest research and thinking on eight
drugs provides data on when and how to best use them in a way
that has not been done before. In fact, the new Guidelines differ
in some instances from the FDA recommendations. One example
is the recommendation that cyclosporine, an immunosuppressant
drug taken orally, may be used as a short-term solution for up to 12
weeks, although FDA guidelines allow its use for up to 12 months.
The new guidelines also state that ustekinumab, commonly
known as Stelara, is safe and effective as a first-line therapy. Previously, its use has been limited to second- and third-line treatment.
Ulthera to Expand Operations
Ulthera, Inc.—a global, growth-stage medical device company pioneering aesthetic and medical applications using its
therapeutic ultrasound platform technology—will expand its
operations to include the manufacturing of various components of its patented technology. This expansion, as well as
continued product development and operational growth, are
anticipated to create more than 100 new, high-wage jobs and
result in $1.68 million of capital investment by 2014.
Ulthera will lease a 35,000 square foot building in Mesa, Arizona, which will house its manufacturing facility and its new
global headquarters. As a result of the expansion, Ulthera will
receive funding from the Arizona Competes Fund, and will
potentially qualify for reimbursement from the state's Job
Training Program under the Arizona Competitiveness Package.
The Ulthera System has been cleared by the FDA for use as a
non-invasive treatment of the face to lift the eyebrow to achieve a desired aesthetic effect. The System combines ultrasound
imaging with focused ultrasound therapy. It has been available
internationally since 2008 and in the US since September 2009.
Ulthera has sold over 800 Ulthera Systems and reports that nearly 80,000 treatments using the System have been performed.
FDA Approves Erivedge (Vismodegib) for Advanced
Basal Cell Carcinoma
Genentech has announced that its ErivedgeTM (vismodegib) capsule has been approved by the FDA for the treatment of adults
with basal cell carcinoma (BCC) that has metastasized, has
come back after surgery or that their healthcare provider has
advised cannot be treated with surgery or radiation. Erivedge
is the first FDA-approved medicine for people with advanced
forms of BCC. It is a capsule that is taken orally once a day.
Erivedge will be available in the United States through specialty
pharmacies. Roche has also submitted a marketing authorization application (MAA) for Erivedge in the European Union (EU).
Erivedge is an oral medicine designed to selectively inhibit
abnormal signaling in the Hedgehog pathway, which is an underlying molecular driver of BCC. Roche and Genentech are
also evaluating Erivedge in a Phase II trial in people with operable forms of BCC.
The FDA approval of Erivedge is based on results from
ERIVANCE BCC (SHH4476g), an international, single-arm, multicenter, two-cohort, open-label, Phase II study that enrolled
104 patients with advanced BCC, including locally advanced
BCC (71) and metastatic BCC (33).
The study showed Erivedge shrank lesions (objective response
rate, or ORR) in 43% (27/63) of patients with locally advanced
BCC and 30% of patients (10/33) with metastatic BCC, as assessed by independent review, the primary endpoint of the
study. The median duration of response was 7.6 months.
Patients with locally advanced BCC had lesions that recurred
after surgery, were not candidates for surgery (inoperable,
or for whom surgery would result in substantial deformity),
recurred after radiotherapy or were not candidates for radiotherapy (radiotherapy was contraindicated or inappropriate).
Study participants received 150 mg of Erivedge orally, once
daily until disease progression or unacceptable toxicity.