Dermatology

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

Efalizumab (Raptiva, Genentech/Xoma) is a humanized monoclonal antibody of CD11a that exerts its effect through the blockade of the interaction between leukocyte function-associated antigen-1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1). FDA recently granted approval for efalizumab in the treatment of chronic moderate-to-severe plaque psoriasis in adults aged 18 years and older. Efalizumab does not achieve clinical response rates equal to cyclosporine or methotrexate, but it lacks the systemic organ toxicities of these agents and is associated with a more rapid onset of action (significant improvements in Psoriasis Area and Severity Index [PASI] response after 2 doses). In addition, efalizumab will likely compete with another approved biologic, alefacept, and off-label use of 2 other biologics currently on the market, etanercept and infliximab. At this time, until further studies comparing efalizumab to other drugs indicated for the treatment of psoriasis are completed and post-marketing surveillance is conducted, the agent?s place on the formulary remains unclear.

New molecular entities, new biologics and new formulations

First line treatment usualy begins with NSAIDs plus a DMARD, but combination therapy and new biologics hold great promise

Biologic therapy for continuous control of plaque psoriasis

New molecular entities and new formulations, FDA actions and generic approvals

Effective rare-disease management programs promise plans cost-effective care, better quality of life for patients

Recent approvals and FDA actions

Recent approvals and new indications

FMCP model urges plans to think outside the cost silo when making formulary decisions

NME: First biologic treatment approved for psoriasis

Alefacept (Amevive) is the first immunosuppressive agent directed specifically at inhibiting the activation of, and possibly killing, T cells, which are involved in the cascade of events leading to psoriatic plaque formation and inflammation. In May, an FDA advisory committee recommended alefacept for approval as a first-line therapy against moderate to severe plaque psoriasis. The authors of this Focus article review the clinical characteristics of alefacept as well as make comparisons with other systemic drugs currently used to treat chronic psoriasis and the likely biologic competitors etanercept and infliximab.

Atopic dermatitis is a chronic, recurrent skin disease characterized by intense pruritis (itching) and inflammation. This supplement which was produced through an unrestricted educational grant from Fujisawa Healthcare, Inc. provides you with an overview of the disease and the development of Topic Immunomodulators. The views and opinions expressed in this supplement do not necessarily reflect the views of Formulary.

An array of both existing and investigational biologic agents are showing efficacy in clearing psoriasis and may prove useful for long-term psoriasis management. So suggests a collection of studies presented at the 60th annual meeting of the American Academy of Dermatology, held recently in New Orleans.

New indication: Biologic cleared for psoriatic arthritis

NME: Topical nonsteroid for second-line eczema Tx

Health plans demand more information to gauge real value of new pharmaceuticals.

New Indication: Oral contraceptive approved for acne