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June 2014 | Volume 13 | Issue 6 | Features | 770 | Copyright © June 2014


was given every four weeks for 24 weeks (ASTERIA I) and 12 weeks (ASTERIA II). In addition, patients continued to receive H1-antihistamine medicines they had been taking for CIU before starting treatment with Xolair.
The efficacy of Xolair in patients 12 years and older who remained symptomatic despite taking H1-antihistamines was assessed using a scale known as the average (mean) weekly Itch Severity Score (ISS) at Week 12. The weekly ISS has potential scores ranging from 0 to 215. In ASTERIA I, Xolair 150 mg improved ISS from the starting measurement by 47 percent (-6.7) and Xolair 300 mg improved ISS from the starting measurement by 66 percent (-9.4) at Week 12, compared to a 25 percent (-3.6) score improvement for patients who received placebo. Also, a larger proportion of patients (36 percent) treated with Xolair 300 mg reported no itch and no hives at Week 12, compared to patients treated with Xolair 150 mg (15 percent), and patients in the placebo group (9 percent). Similar results were observed for the ASTERIA II study.
Xolair for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma who have had a skin or blood test that is positive for allergic asthma and whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids and chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 -antihistamine treatment.
Xolair is not used to treat other allergic conditions, other forms of urticaria (hives), acute bronchospasm (serious and sudden breathing problems) or status asthmaticus (acute, severe, prolonged asthma attack that can be life threatening). Xolair is not for use in children less than 12 years of age.

Dalvance(TM) for Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Durata Therapeutics, Inc. has announced that the FDA’s Anti- Infective Drugs Advisory Committee voted 12 to 0 that Durata has provided substantial evidence of the safety and effectiveness of its investigational drug, DalvanceTM (dalbavancin) for injection, for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillinresistant Staphylococcus aureus (MRSA). While not bound by the guidance provided by the Committee, the FDA will consider the Committee's deliberations as part of its review of the New Drug Application (NDA) for Dalvance, which was accepted for priority review by the FDA in November 2013 with an action date of May 26, 2014.
A total of 21 clinical trials have been conducted with dalbavancin in the entire clinical program, with the five Phase 3 trials evaluating nearly 3,000 patients. Two Phase 3 trials, DISCOVER 1 and DISCOVER 2 were conducted under a Special Protocol Assessment (SPA) with the FDA and included more than 1,300 patients with ABSSSI.
Dalvance is a second generation, semi-synthetic lipoglycopeptide, which consists of lipophilic side-chains attached to glycopeptides. If approved, Dalvance would be the first drug for ABSSSI requiring only two once-weekly 30-minute intravenous doses (1000 mg on Day 1 and 500 mg on Day 8). Dalvance demonstrates bactericidal activity in vitro against a broad range of bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species.

Neotensilâ„¢ Daily Under-Eye Reshaping Procedure

Neotensil™ Daily Under-Eye Reshaping Procedure is an innovative, revolutionary solution that reshapes and transforms the appearance of eye bags and lax skin underneath the eyes, within one to three hours. Invented by Living Proof scientists and world-class dermatologists, Neotensil creates an invisible, wearable polymer film that performs like invisible shapewear for aging skin. It represents a new category of non-invasive, at-home anti-aging procedures powered by Living Proof’s breakthrough skin technology, Strateris® Strateris forms a breathable, invisible and wearable film that adheres to the skin and intrinsically wants to shrink and become flat, reshaping and compressing the appearance of bulges and underlying, lax skin. Future product iterations relying on the Strateris technology could potentially offer a diverse array of fresh approaches to cosmetic challenges, such as combating the effects of aging on the forehead, neck or décolletage, as well as medical solutions for dermatological conditions.