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
Neotensilâ„¢ 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.