FDA Approvals & News
Important Warning for Infliximab
Centocor has issued a warning for infliximab (Remicade) to alert healthcare professionals about postmarketing hematologic adverse events, including leukopenia, neutropenia, thrombocytopenia and pancytopenia. In some cases, fatalities have resulted.
The company noted in a written statement that “the causal relationship to Remicade therapy remains unclear.” In addition, the letter specified that “. . . caution should be exercised in patients being treated with Remicade who have ongoing or a history of significant hematologic abnormalities.”
To date, approximately 509,000 patients worldwide have been treated with this drug, which is indicated for treatment of rheumatoid arthritis and Crohn’s disease and was approved for treatment of psoriatic arthritis by the European Union in late July of this year.
In addition, updates to the drug’s labeling were also made to the section “Warnings on Neurologic Events” to highlight the following:
• Describe rare cases of CNS manifestation of systemic vasculitis
• Warn that discontinuation of Remicade should be considered in patients who develop CNS adverse reactions.
The prescribing information was further updated to add the following adverse events that were reported during post-approval use of Remicade, which has been approved since August of 1998. These adverse events include neutropenia, pericardial effusion and systemic and cutaneous vasculitis.
To report any adverse events, contact the FDA’s MedWatch reporting program at (800) FDA-1088, or log on to www.fda.gov/medwatch.

Expanded Indication for Humira
Adalimumab (Humira), a tumor necrosis factor alpha antagonist that is currently under study for treatment of psoriasis and psoriatic arthritis, has received FDA approval for an expanded indication to improve physical function in patients with moderately to severely active rheumatoid arthritis.
In 2002, the drug was previously approved to reduce signs and symptoms and inhibit the progression of structural damage in adult patients with moderately to severely active RA who have had an inadequate response to one or more disease modifying anti-rheumatic drugs.
The most recent indication was based on data from a
52-week open-label continuing study of 457 RA patients with inadequate response to methotrexate. Improvements were noted as early as 2 weeks after the first dose of Humira, and improvements were maintained through 2 years of treatment.
Humira is administered every other week via subcutaneous injection. The drug is currently undergoing clinical trials for juvenile rheumatoid arthritis, Crohn’s disease and ankylosing spondylitis, in addition to the already mentioned trials for psoriasis and psoriatic arthritis.

First-Time Generics for Dermatologic Conditions
In early August, the FDA approved two first-time generics for dermatologic conditions.
1. Ciclopirox Topical Suspension 0.77%, a topical anti-fungal, is now available. This lotion’s generic reference listed drug is Loprox Topical Suspension.
2. Alclometasone dipropionate 0.05%, a topical ointment, was also approved. This version of the drug was found to be therapeutically equivalent to the listed drug, Aclovate, which is manufactured by GlaxoSmithKline.

Three Nutritional Supplements for Skin Care Ordered off the Market
A U.S. District Court in New Jersey ordered LaneLabs to stop production and distribution of three products.
The products BeneFin, MGN3 and SkinAnswer are under scrutiny, and the court’s ruling is intended to focus on the marketing claims surrounding the products. The products are not being recalled, and any of these products purchased from LaneLabs prior to July 9, 2004, can still be legally sold.
According to the ruling, the three products are misbranded as nutritional supplements and should be labeled as new drugs and need to obtain FDA approval before they’re potentially reintroduced into the market.
LaneLabs voluntarily stopped production and sales of two of its other products, Noxylane4 and SunSpotES, even though they weren’t named in the court order.

Antibiotic for Skin and Skin Structure Infections
AstraZeneca Pharmaceuticals has submitted a supplemental new drug application (sNDA) with the FDA seeking a new indication for its antibiotic meropenem for injection (Merrem I.V.), to treat patients with complicated skin and skin structure infections.
The drug is already approved in the United States as a single agent therapy for the treatment of intra-abdominal infections and bacterial meningitis.

Mapping Anthrax’s Entre into Human Cells
Scientists now know a detailed “snapshot” of how the anthrax toxin enters human cells, a finding that has potential not only for finding ways to block the toxin but also for using the toxin as a possible tumor treatment.
To make this discovery, researchers used an intense X-ray beam to find the position of atoms in a crystal form of the protein complex, according to the National Institutes of Health (NIH). They created a 3-D molecular image of an anthrax toxin’s protein docked to a human anthrax toxin receptor.
According to the NIH, this discovery of the newly revealed structure is likened to having a “roadmap that connects two cities” where previously what was available to scientists were separate images of the anthrax protective antigen protein and the human receptor site. This is the first opportunity scientists have had to view the protein and the receptor site interacting.
With the 3-D image, scientists can view clearer ways to block the anthrax toxin from entering human cells. The discovery may eventually yield a new way to treat tumors. Using a genetically modified anthrax toxin, scientists believe they can link the toxin to a cell receptor that’s commonly found in cells that line the blood vessels of tumors. In this scenario, the toxin would kill tumor cells but spare ordinary cells of any harm.

Clarification
In the May issue of Skin & Aging, we wish to correct mention of a study that was cited in the article “Atopic Dermatitis: Employing a New Treatment Paradigm” (DiRuggiero D, Smith J. 12(5):58-67.) The correct citing of the study is as follows: Torok HM, et al. Cloderm Cream 0.1% Used Concomitantly with Tacrolimus Ointment 0.1% in Atopic Dermatitis. Cutis. August 2003:(72):161-166.