FDA Panel Backs Radiesse Approval, With Conditions

20 Dermatologic Surgery S KIN & ALLERGY N EWS • October 2006
Two Indications Green Lighted
Radiesse from page 1
in how to use the product received unanimous
endorsement from the panel. Bio-
Form is planning a training program and
will incorporate some of the panel’s recommendations,
Stephen L. Basta, president
and CEO of the company, said at the
meeting.
Another condition recommended for
the HIV-associated lipoatrophy indication
was completion of the 18-month followup
study being conducted by BioForm,
which panelists said should include data on
the texture of the implant, ease of injection,
events that require further evaluation,
and time needed to reinjection. The
label should also state that Radiesse was
studied specifically in patients with HIVrelated
lipoatrophy and that use for other
indications was unproved.
Nasolabial Fold Indication
For the nasolabial fold indication, the panel
agreed that Radiesse was effective for up
to 6 months, the length of the study submitted
for approval. But as a condition for
approval, the panel recommended that the
company conduct a postapproval study
specifically looking at the duration of the
cosmetic effects beyond 6 months, the effect
of repeated injections, and safety.
Other conditions were that the company
conduct a study of Radiesse in “people
of color”—who tend toward hypertrophic
scarring and keloid formation and were underrepresented
in the study submitted to
the FDA for approval of this use—and
that a statement be added to the product’s
label cautioning that safety and efficacy of
the product in black patients was not
known. In this study, there were 2 African
Americans, 11 Hispanic patients, and 2 patients
whose race was described as “other.”
(In the lipoatrophy study, about half the
patients were Fitzpatrick skin type IV-VI,
which was not associated with a greater
rate of adverse events; the company cited
these to address the issue of safety for
treating nasolabial folds. But the FDA executive
summary noted that the two patient
populations are not homogeneous
and that the HIV-positive patients in the
lipoatrophy study may have had a “diminished
capacity to mount a hypersensitivity
reaction.”)
According to the company, the proposed
label already includes a statement that the
product has not been studied for use in lip
augmentation and that adverse events have
been reported, so the panel did not include
this as a condition. The use of Radiesse for
lip augmentation has not been studied, and
based on reports the company has received,
lips are the most common site of
nodular formation associated with use of
Radiesse, Mr. Basta said.
Register now for this archived webcast at www.viralskindiseases.com
Introduction
Stephen K. Tyring, MD, PhD, MBA
Professor of Dermatology
Department of Dermatology
University of Texas Health Science Center
Houston, Tex.
Human Papillomaviruses:
Basic Virology to Clinical Management
Stephen K. Tyring, MD, PhD, MBA
Molluscum Contagiosum
and Treatment Options
Douglas W. Kress, MD
Chief of Pediatric Dermatology
Children’s Hospital of Pittsburgh
Pittsburgh, Penn.
Treatment of Cutaneous Warts:
An Updated Inventory
of Therapeutic Options
Robert B. Skinner, MD
Professor of Medicine
Department of Dermatology
University of Tennessee
Health Science Center
Memphis, Tenn.
PROGRAM DESCRIPTION
Viral skin diseases represent a major component in the busy practices of dermatologists. In this activity,
the focus is on the most common cutaneous viral diseases, genital/anal warts (condylomata acuminatum)
and common warts, caused by human papillomaviruses (HPV), and molluscum contagiosum, caused by
Poxviruses.
The manifestations of cutaneous viral infections range from simple erythematous, macular presentations to
papules, vesicles, pustules, ulcers, and crusting that may represent any of a long list of possible etiologies.
Clinicians must be able to accurately assess and differentiate among these manifestations and presentations,
particularly now because of the emerging possibility that the causative organisms may be the etiologic agents
responsible for smallpox infections or disseminated vaccinia. The poxviruses, especially, may mimic or be
mimicked by vaccinia, and clinicians should know the differences in the morphology of the lesions as well as
in the presentation, timing, and progression of these lesions.
Advances in the understanding of the natural history and treatment of common viral skin diseases highlight
the need for a continuing educational process that guides the clinician in patient management, including the
latest treatment options, such as topical immune response modifier therapy.
This activity will provide dermatologists with current information regarding the nature of viral skin diseases
caused by HPV and poxviruses and will help clinicians remain up-to-date on patient applied and physician
applied therapies in the treatment of genital warts, common warts, and molluscum contagiosum.
INTENDED AUDIENCE
This activity has been developed for dermatologists, primary care physicians, and other clinicians who are
involved in the diagnosis and treatment of viral skin diseases.
EDUCATIONAL OBJECTIVES
After reading this supplement and taking the test, participants should be able to:
• Summarize the current understanding of the pathogenesis of human papillomavirus (HPV) infections of
the skin—as manifested by genital/anal and common warts—and the role of local immune responses in
the clearing of infection.
• Discuss the HPV types that are associated with external genital/anal warts and with cervical
malignancies, and explain the role of diagnostic testing in the management of patients with external
genital/anal warts.
• Recognize the most common presentations of human papillomavirus (HPV) and poxvirus infections, as
well as the atypical morphologic characteristics that must be considered in diagnosing various types of
warts and molluscum contagiosum.
• Describe the methods that may be used to confirm a clinical diagnosis of molluscum contagiosum, and
explain when such methods should be used.
• List and explain the destructive/ablative methodologies and the pharmacologic treatments that are
currently available for treating genital/anal and common warts and molluscum contagiosum.
• Name and describe the factors that should be considered in choosing a specific therapeutic regimen
for individual patients.
ACCREDITATION STATEMENT
This activity has been planned and implemented in accordance with the Essential Areas and Policies of
the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of
the Elsevier Office of Continuing Medical Education (EOCME) and Skin & Allergy News. The EOCME
is accredited by the ACCME to provide continuing medical education (CME) for physicians.
CME CREDIT STATEMENT
The EOCME designates this educational activity for a maximum of 1 AMA PRA Category 1 Credit .
Physicians should only claim credit commensurate with the extent of their participation in the activity.
Financial Support: This CME activity is supported by an educational grant from
Panel Members’ Concerns
Like others on the panel, Dr. Michael
Miller, professor and deputy chairman in
the department of plastic surgery at the
University of Texas M.D. Anderson Cancer
Center, Houston, agreed that there
was reasonable assurance that Radiesse
was safe and effective for the lipoatrophy
indication. The benefits for this population
were “enormous,” and although the cosmetic
effect of Radiesse was not permanent,
its effect was “good, if not better
than anything else” used for HIV-associated
lipoatrophy. He cautioned, however,
that Radiesse works by creating a volume-filling
scar, which is acceptable only
if it achieves the desired effect.
Several panelists agreed with Dr. Miller,
who said that the study convincingly
showed efficacy and that its long history
of use for various indications helped mitigate
the unknowns.
Dr. Michael Olding, chief of the division
of plastic surgery, George Washington
University, Washington, said that while
he had concerns about the lack of information
in histology and the length of
durability, he pointed out that no significant
complications were observed in the
study and the quality of improvements
seen in the patient photographs, in his
view, “surpassed” the results of other
treatments, at least photographically.
The dermatologist on the panel, Dr.
Amy E. Newburger of Scarsdale, N.Y.,
who voted against approval for both indications,
expressed concern about the extensive
off-label cosmetic use of Radiesse
that has already occurred and is expected
post approval, and about the lack of human
histologic data for the product. She
said the study in HIV-associated lipoatrophy
was not large or rigorous enough to
make her feel comfortable about effectiveness
and safety, referring to reports of
serious adverse reactions associated with
Radiesse reported to the FDA’s adverse
event reporting database, including reports
resulting from unapproved use in lips.
And while the study on the nasolabial
folds indication was a better study than the
lipoatrophy study, she said there were
“too many unknowns remaining” to vote
for approval for this indication. Radiesse
Continued on following page