CIU is diagnosed when hives occur without an identifiable
cause, spontaneously present, and reoccur for more than six
weeks. CIU can have burdensome symptoms including swelling,
severe itch, pain, and discomfort that may last for many
months and even years. Approximately 1.5 million people in
the U.S. develop CIU at some stage in their life. Women are
twice as likely as men to experience CIU and most develop
symptoms between the ages of 20 and 40.
Xolair is the first biologic medicine and first medicine approved
by the FDA for CIU since non-sedating H1-antihistamines. Xolair
is approved for people 12 years and older with CIU who remain
symptomatic despite treatment with H1-antihistamine therapy.
Xolair is not used to treat other forms of urticaria (hives) and
is not for use in children less than 12 years of age. It is jointly
developed by Genentech and Novartis Pharma AG and is co-promoted
in the U.S. with Novartis Pharmaceuticals Corporation.
The efficacy and safety profile of Xolair for the treatment of CIU
was evaluated in two clinical studies called ASTERIA I and ASTERIA
II. In these studies, patients 12 to 75 years old received
doses of Xolair at 150 mg, 300 mg or placebo. Xolair or placebo
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 Grampositive
bacteria, including methicillin-resistant 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.
Neotensil
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.