June 2011 | Volume 10 | Issue 6 | Feature | 683 | Copyright © 2011
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval. We trust you will find this information beneficial to your practice and research.
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FDA Approves Rituxan and Steroid for Severe Vasculitis
Genentech and Biogen Idec have announced that the FDA approved Rituxan (rituximab), in combination with corticosteroids, as a new medicine for adults with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA).
The approval is based on a National Institutes of Healthsponsored study known as RAVE (Rituxan in ANCA-Associated Vasculitis) that showed Rituxan to be comparable to the current standard of care, cyclophosphamide (CYC), in inducing disease remission at six months in adults with WG and MPA. RAVE is a multicenter, randomized, double-blind, active-controlled study. In the study, patients were randomized to receive either Rituxan for four weeks with corticosteroids, or the control treatment of oral CYC with corticosteroids daily for three to six months in the remission induction phase. Once remission was achieved or at the end of the six-month remission induction period, patients in the CYC group were to receive daily azathioprine to maintain remission. Patients in the Rituxan group were not to receive additional therapy to maintain remission. In the Rituxan group, 64 percent (63/99) of patients reached the primary endpoint of complete remission at six months, defined as a zero score on the Birmingham Vasculitis Activity Score for Wegener's Granulomatosis (BVAS/WG) and successfully tapered off corticosteroids, compared with 53 percent (52/98) of patients who received CYC with corticosteroids. The BVAS/WG is an instrument used in clinical trials to define and measure worsening or improvement of AAV disease activity among patients.
Infections were the most commonly reported adverse events and occurred in 62 percent (61/99) of patients in the Rituxan group and 47 percent (46/98) of patients in the control group and were most frequently upper respiratory tract infections. The study evaluated specific serious adverse events of concern in this patient population including deaths, development of certain forms of cancers, blood disorders, infections, cardiovascular events, hospitalizations and infusion reactions. At six months, 33 percent (n=32) of those taking CYC developed one of the adverse events versus 22 percent (n=22) of those on Rituxan.
LEO Pharma Launches $0 Copay Program for Taclonex Plaque Psoriasis Treatments
LEO Pharma has launched a $0 copay program for its plaque psoriasis treatments, Taclonex Ointment and Taclonex Scalp. Patients can now obtain a patient savings card via their healthcare provider or at the taclonex website that can be presented along with their prescription to cover their copay costs. The program offers eligible patients copay assistance for up to six prescriptions with a maximum benefit of $200 off per prescription. There is no activation required, and the card is valid until December 31, 2012, with some applicable restrictions.
Psoriasis is a non-contagious, chronic disease of the immune system that affects an estimated 125 million people worldwide. Plaque psoriasis generally appears as patches of raised, red skin covered by flaky white buildup of dead skin cells. These patches most often appear on the scalp, knees, elbows and torso, are often itchy and painful, and can crack and bleed.
Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Ointment is approved for use on the skin to treat psoriasis vulgaris (plaque psoriasis) in adults 18 years of age and older and should be applied to affected areas once daily for up to four weeks. Taclonex Scalp (calcipotriene 0.005% and betamethasone dipropionate 0.064%) Topical Suspension is approved to treat moderate-to-severe psoriasis vulgaris of the scalp in adults 18 years and older and should be applied to affected areas on the scalp once a day for two weeks or until cleared. If the affected area is not cleared, Taclonex Scalp Topical Suspension may be continued for up to eight weeks, not exceeding the recommended weekly dose of 100 grams. Neither product is recommended for use on children.
Taro Receives FDA Approval for Imiquimod Cream, 5%
Taro Pharmaceutical Industries Ltd. has received approval from the FDA for its Abbreviated New Drug Application (ANDA) for Imiquimod Cream, 5%.
Taro's imiquimod cream is a prescription pharmaceutical product used for topical treatment of actinic keratosis and external genital warts and is bioequivalent to Aldara Cream, 5% of Graceway Pharmaceuticals, LLC.