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Drug Treatments for Skin Disease Introduced in 2009

Drug Class Generic/Trade
Company Names
Indication Approving
Regulatory Agency

Actinic Keratosis

Imiquimod Cream 3.75%
Zyclara™
Graceway Pharmaceuticals

This immune response modifier was approved for the topical treatment of multiple actinic keratoeses located on the face or balding scalp in adults.

Health Canada

Antibacterial

Telavancin
Vibativ™
Theravance Inc./Astellas Pharma

Approved as a once daily injectable antibiotic for the treatment of adults with complicated skin and skin structure infections caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant and methicillin-susceptible strains.

Health Canada;
US FDA

Anticancer

Photopheresis System
THERAKOS™ CELLEX™
Johnson & Johnson

Approved for the palliative treatment of skin manifestations of cutaneous T-cell lymphoma (CTCL) unresponsive to other forms of treatment.

Health Canada

Romidepsin
ISTODAX®
Gloucester Pharmaceuticals

This histone deacetylase inhibitor was approved for the treatment of CTCL in patients who have received at least 1 prior systemic therapy.

US FDA

Antihistamine

Levocetirizine Dihydrochloride
XYZAL®
UCB/sanofi-aventis

Approved for the relief of symptoms from perennial allergic rhinitis and chronic idiopathic urticaria in children =6 months of age.

US FDA

Antipsoriatic

Calcitriol Ointment
Vectical™
Galderma Laboratories

Approval was granted to this novel topical vitamin D3 agent for the treatment of mild-to-moderate plaque psoriasis in adults.

US FDA

Etanercept
Enbrel®
Wyeth

A new indication was granted to this biologic for the treatment of chronic severe plaque psoriasis in children aged =8 years.

EMEA

Ustekinumab
Stelara™
Centocor Ortho Biotech/
Janssen-Ortho

This first-in-class human monoclonal antibody that selectively targets the cytokines interleukin-12 and interleukin-23 was approved for the treatment of moderate-to-severe plaque psoriasis in adults =18 years of age.

EMEA;
US FDA

Antiviral

Acyclovir + Hydrocortisone Cream
Lipsovir®/Xerclear®
Medivir AB

This topical product combining an antiviral with an anti-inflammatory was approved for the prevention and treatment of recurrent herpes labialis. Indicated for adults and children =12 years of age.

EMEA;
US FDA

Dermal Fillers
and Injectables

AbobotulinumtoxinA
Dysport™
Medicis/Ipsen

Approval of this acetylcholine release inhibitor and neuromuscular blocking agent was granted for the temporary improvement in the appearance of moderate-to-severe glabellar lines in adults aged <65.

US FDA

Botulinum Toxin - Type A
Azzalure®
Galderma/Ipsen

This neurotoxin received approval for the temporary improvement in the appearance of moderate-to-severe glabellar lines in adult patients <65 years of age.

Agence Française de Sécurité Sanitaire de Produits de Santé (France)

Collagen-based Dermal Filler
Evolence®
Ortho Dermatologics

A labeling supplement was approved, that includes efficacy and safety data through 12 months, for this collagen-based dermal filler for the correction of moderate to deep facial wrinkles and folds.

US FDA

Injectable Poly-L-lactic Acid
Sculptra Aesthetic®
sanofi-aventis US

Approved for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.

US FDA

Hand Eczema

Alitretinion
Toctino®
Basilea Pharmaceutica

Approved as a once daily oral retinoid treatment for adults with severe chronic hand eczema refractory to potent topical corticosteroids.

Health Canada; Swissmedic; Austria; Belgium; Luxembourg

HIV/AIDS

Darunavir
PREZISTA™
Tibotec/Janssen-Ortho

This antiretroviral agent was approved for the treatment of HIV infection to be used once daily in treatment-naïve adults in combination with other antiretroviral agents, such as ritonavir.

Health Canada

Etravirine Tablets
INTELENCE®
Tibotec Therapeutics

Approved for use in treatment-experienced adults who are encountering virologic failure with HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor and other antiretroviral agents.

US FDA

Lice

Benzyl Alcohol Lotion 5%
Ulesfia™
Sciele Pharma

This new prescription non-neurotoxic medication was approved for the treatment of head lice in patients =6 months of age.

US FDA

Postherpetic Neuralgia

Capsaicin 8% Transdermal Patch
Qutenza™
NeurogesX, Inc.

Approved for the management of neuropathic pain due to postherpetic neuralgia. This medicated skin patch can provide up to 12 weeks of pain reduction following a single 1-hour application.

EMEA;
US FDA

Psoriatic Arthritis

Golimumab
Simponi™
Centocor Ortho Biotech/
Schering-Plough

This once monthly, subcutaneous, anti-TNF-a human monoclonal antibody was approved for the treatment of moderate-to-severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

EMEA;
Health Canada;
US FDA

Vaccines

Human Papillomavirus Bivalent
(types 16 and 18)
Recombinant Vaccine

Cervarix®
GlaxoSmithKline

Approved for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18; for use in girls and women aged 10-25 years.

US FDA

Human Papillomavirus Quadrivalent
(types 6, 11, 16, and 18)
Recombinant Vaccine

Gardasil®
Merck & Co.

Approved for use in boys and men 9-26 years of age for the prevention of genital warts caused by HPV types 6 and 11.

US FDA

Wound Care

Small Molecule
Oxychlorine Compound

Microcyn® Skin and Wound Gel
Oculus Innovative Sciences

Clearance was given to market this product (both as a prescription and an OTC formulation) for the management of exuding wounds (e.g., leg ulcers, pressure ulcers, and diabetic ulcers) and for the management of mechanically or surgically debrided wounds.

US FDA

Other

Estradiol Vaginal Tablet
Vagifem®
Novo Nordisk

Approved for the treatment of atrophic vaginitis due to menopause.

US FDA


In this issue:

  1. Pruritus: Control of Itch in Patients Undergoing Dialysis
  2. Drug Treatments for Skin Disease Introduced in 2009
  3. Update on Drugs and Drug News - February 2010