FDA Approvals & NewsHumira Receives Expanded Indication for Psoriatic ArthritisAdalimumab (Humira) has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for treating psoriatic arthritis. The new indication for Humira includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis (PsA). Humira received approval to treat psoriatic arthritis in October 2005. The approval for the expanded indication was based on  results from an extension of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT), the largest randomized, placebo-controlled biologic trial in PsA. ADEPT was a Phase III, controlled study in 313 patients with moderate to severe PsA, who had an inadequate response to therapy with non-steroidal anti-inflammatory drugs. In the study, patients were randomized to receive either Humira 40 mg every other week or placebo. At week 24, 285 patients elected to enroll in a 24-week open-label extension.Results for inhibiting progression of structural joint damage were as follows:Patients taking Humira experienced significantly less joint damage than patients taking placebo. Joint damage was assessed with X-rays taken at baseline and weeks 24 and 48, using the modified total Sharp score (mTSS), which is a measure of joint damage progression. (A smaller change in mTSS reflects less progression of joint damage, with a positive score indicating worse radiographic damage.) • At week 24, the co-primary endpoint (the average change in joint damage, as measured by a mean change in mTSS) was 10 times greater in patients who took placebo than those who received Humira (0.9 and -0.1, respectively; p<0.001). More than three times as many patients on placebo (29%) experienced joint damage compared to patients taking Humira (9%) at week 24. • Results in the Humira group were maintained through 48 weeks, the mean change in mTSS compared to baseline was -0.2 at 48 weeks.Results for improving physical function were as follows:Patients taking Humira showed significant improvement in physical function as assessed by the Health Assessment Questionnaire Disability Index (HAQ) score and the Short Form-36 Health Status Survey (SF-36). HAQ scores assess ability to perform daily activities such as getting dressed and walking. • At week 24, statistically significant improvements in HAQ (p<0.001) were achieved by patients in the Humira group compared to placebo. Patients taking Humira also showed statistically significant improvement compared to placebo in the SF-36 Physical Component Score (p<0.001). The SF-36 is a broad questionnaire that examines the physical and mental impact on patients. • Improvements were maintained through week 84.Humira is also approved in the United States for treating moderate to severe rheumatoid arthritis (RA) and active ankylosing spondylitis.  First Generic Version of KlaronThe FDA has approved the first generic version of Dermik’s acne treatment sulfacetamide sodium topical suspension 10% strength (Klaron). Fougera, a division of Altana, was granted approval for the generic version.  New Indication for CoolTouch CTEV Endovenous LaserCoolTouch Inc has received 510(K) clearance from the FDA for its CoolTouch CTEV 1320 nm laser system to treat superficial incompetent tributary veins associated with varicose veins and varicosities. This approval confirms the CoolTouch CTEV is a safe and effective treatment of incompetent tributaries and the reflux of the Great Saphenous Vein (GSV) and Small Saphenous Vein (SSV), according to the company.CoolTouch is the first to receive tributary FDA approval, according to the company.  New Cosmetic Tissue Augmentation Product Anika Therapeutics Inc. is nearing approval for its cosmetic tissue augmentation product.The company received an “approvable letter” from the FDA for the product, which is based on Anika’s chemically modified hyaluronic acid (HA) proprietary technology and incorporates lidocaine. This injectible soft tissue filler is for wrinkles, scars and lip augmentation. Although the approvable letter does not mean the product is approved for use, it normally indicates a request for more data or a need to further discuss labeling options.The company expected to receive final approval by the end of the year, and it noted that it hoped to launch this product in the middle of 2007.  In Brief…Charles W. Stiefel Has Been…nominated for the national Ernst & Young Entrepreneur Of The Year 2006 Award. The Chief Executive Officer and Chairman of the Board at Stiefel Laboratories has also endowed a chair in the Department of Dermatology and Cutaneous Surgery at the University of Miami Leonard M. Miller School of Medicine. The Stiefel Laboratories, Inc. Chair in Medical Dermatology will help advance the school’s dermatology department.Foamix Ltd. Announced…that it has licensed a novel topical foam product, PerFoam 1% for the contemporary treatment of head lice to Taro Pharmaceutical Industries Ltd. Under the terms of the agreement, Foamix will transfer technology to Taro and Taro will upscale, manufacture, register and commercialize PerFoam1% for distribution in Israel and the Palestinian Territories. Stiefel Laboratories Announced…the appointment of Dr. Larry Staubach to the newly created position of Vice President, Global Medical Affairs and Pharmacovigilance. Dr. Staubach will coordinate all worldwide medical affairs activities to support the commercial strategies of Stiefel Laboratories. He also will be responsible for pharmacovigilance and drug safety worldwide. This position was created to to help integrate Stiefel’s Research and Development activities into a global organization.Syneron Announced…its next wave of fat treatment for its VelaSmooth cellulite reduction system line, the Contour Applicator. This smaller applicator is currently under study to evaluate the use of the device to reduce thigh circumference. Clinical trials, to date, have revealed the Contour Applicator has increased benefits from the original VelaSmooth treatment in contouring and shaping the body, specifically in smaller areas.Cholestech Corporation Announced…that its Cholesterol Reference Method Laboratory Network (CRMLN)-certified, CLIA-waived Cholestech LDX System enables physicians prescribing isotretinoin to obtain laboratory-accurate blood results in less that 5 minutes with a finger stick. The need for accurate testing of cholesterol and liver function in istotretinoin patients was underscored by a study by the University of California, San Francisco, and published in the Archives of Dermatology, which showed that abnormalities in cholesterol and liver enzymes in Accutane patients are even more prevalent than anticipated.