Dermatology

FDA has approved ipilimumab (Yervoy, Bristol-Myers Squibb) to treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer.

In the beginning of September, FDA released a safety announcement reminding healthcare providers of an increased mortality risk associated with the use of the intravenous antibiotic tigecycline (Tygacil) compared to that of other drugs used to treat similar serious infections.

New biologic: Ustekinumab (Stelara) was approved on September 25, 2009, for the treatment of adult patients aged 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

New molecular entity: Telavancin for injection (Vibativ) was approved on September 11, 2009, for the treatment of complicated skin and skin-structure infections (cSSSIs)

Ustekinumab is a novel investigational human monoclonal antibody (mAb) that is pending approval for the treatment of plaque psoriasis. Subcutaneous administration of ustekinumab has demonstrated efficacy in both phase 2 and 3 trials.

New formulation: Calcitriol (Vectical), a Vitamin D analogue, was approved on January 23, 2009, for the treatment of mild-to-moderate plaque psoriasis

Genentech informed healthcare professionals that a 70-year-old patient who has been treated with efalizumab (Raptiva) for chronic psoriasis for >4 years has developed progressive multifocal leukoencephalopathy (PML), a rare, progressive disease of the central nervous system that is usually fatal.

Retapamulin ointment, 1% is now approved by FDA as an antibacterial agent for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes.

New research presented at the AAD's 65th Annual Meeting regarding treatment of biologic psoriasis with adalimumab and efalizumab.

Infliximab acts through the inhibition of tumor necrosis factor (TNF)-alpha, which is responsible for the induction of inflammatory cytokines, the enhancement of leukocyte migration, and the activation of neutrophil and eosinophil functional activity. Infliximab was approved on September 27, 2006, for the treatment of adult patients with chronic severe (ie, extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

This agent targets the overexpression of histone deacetylase (HDAC) or the aberrant recruitment of HDACs to oncogenic transcription factors in cancer cells. Vorinostat was approved on October 6, 2006, for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent, or recurrent disease following 2 systemic therapies.

A review of adverse event data associated with the synthetic vitamin A retinoid isotretinoin between 1997 and 2002 suggests that the acne treatment is a "probable" cause of inflammatory bowel disease (IBD) and may precipitate its presentation within a certain subset of patients who are either predisposed to the disease or have subclinical symptoms.

An ointment containing calcipotriol (50mcg/g) plus betamethasone diproprionate (0.5mg/g) demonstrated significant efficacy against psoriasis within 4 weeks compared with 12 weeks of biological therapy, regardless of disease severity, as measured by the Psoriasis Area and Severity Index (PASI), according to a meta-analysis recently reported in the International Journal of Dermatology.

A lower dose of the oral retinoid acitretin is effective for moderate-to-severe psoriasis and can minimize adverse effects, according to a study presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. Current practice is to administer the maximal tolerated dose of 25 mg to 50 mg acitretin daily.

CNTO 1275, an anti-IL12p40, maintains efficacy in clearing plaque psoriasis for up to 24 weeks after 1 dose, according to results of a phase 2 study presented by researchers at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. The subcutaneously injected agent targets both interleukin 12 and 23, two key cytokines in type 1 immune responses, said study author Gerald G. Krueger, MD, of the department of dermatology, University of Utah Health Sciences Center, in Salt Lake City, Utah.

Mild to moderate psoriasis is generally treated first with topical corticosteroids and other topical remedies. When the disease is widespread or unresponsive to topical agents, ultraviolet phototherapy may be used at home or in the physician's office.

Psoriasis is a chronic, inflammatory dermatologic disease that can have a significant physical and psychological impact on affected patients.

April FDA Pipeline

FDA new indications and the latest generics

New indications

Several drug regimens are available for asthmatics, but the key to asthma control is to reduce airway inflammation, and therefore limit the need for short-term rescue medications.

New combinations

Although the mechanism of action of imiquimod is unknown, an open-label study suggests that the drug may act by increasing the filtration of lymphocytes, dendritic cells, and macrophages into the tumor lesion. Imiquimod was approved on July 14, 2004, for an expanded indication to include the treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults.

New molecular entities and FDA news

Biologic approved for plaque psoriasis

Second-generation antihistamines bestfor mild allergies; plans curb use of leukotriene modifiers

FDA Actions in brief

New medical devices, FDA actions and first-time generics

Later this year, U.S. Surgeon General Dr. Richard Carmona will release a report, "The Health Consequences of Smoking," and a new database of medical research, treatment and smoking prevention information. This year's report will come 40 years after Americans first learned there were significant consequences of smoking, thanks to the efforts of then-Surgeon General Dr. Luther Terry, who was appointed during the Kennedy administration.

New indications and new combinations; first-time generic approvals