Abbott cleared to market Crohn's
drug in US
Abbott Laboratories has received FDA approval to market Humira as a
treatment for reducing the symptoms and inducing clinical remission in adults
with Crohn's disease who have had an inadequate response to conventional
therapy.
Humira is also indicated for reducing the signs and symptoms and inducing
clinical remission in these patients if they have also lost response to or are
intolerant to infliximab, the only other approved biologic for treatment of
Crohn's disease.
Crohn's disease is a serious chronic, inflammatory disease of the
gastrointestinal tract. Common symptoms of Crohn's disease include diarrhea,
cramping, abdominal pain, weight loss, fever, and in some cases, rectal
bleeding.
Humira also comes with the strongest possible warning because the drug has
been associated with serious infections, sepsis, tuberculosis and
opportunistic infections, including fatalities.
This approval establishes Humira as the first and only self-administered
biologic for the treatment of Crohn's disease. Crohn's disease is the fourth
FDA approval in immune-mediated diseases for Humira.
"The approval in Crohn's disease extends the reach of Humira beyond
rheumatology and dermatology to an underserved patient population in
gastroenterology," said Eugene Sun, vice president, Global Pharmaceutical
Clinical Development at Abbott.
"In addition to rapid and sustained response, Humira offers patients with
moderate to severe Crohn's disease the convenience of self-injection in the
comfort of their home."
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The FDA has approved Cymbalta to treat generalized anxiety disorder (GAD).
Eli Lilly's Cymbalta has gained the approval of the FDA for use in
patients with GAD. The expanded indication is positive news for Cymbalta,
which is already approved in the US for the treatment of major depressive
disorder and the management of diabetic peripheral neuropathic pain.
Cymbalta (duloxetine HCl) is serotonin and norepinephrine reuptake inhibitor (SNRI),
which is a class of drugs that is primarily indicated for the treatment of
depression, but may also be prescribed for a variety of other mental health
issues, including panic, anxiety and eating disorders.
The FDA's approval of Cymbalta to treat GAD as well as depression and
neuropathic pain is based on three randomized, double-blind studies in
non-depressed adults with the disorder. The results of these studies have
shown that 46% of patients treated with Cymbalta had improved anxiety-related
symptoms as compared to 32% of patients treated with a placebo. In addition,
46% of patients who took Cymbalta experienced an improvement in their
abilities to perform everyday activities related to work, home and social
situations as compared to 26% of patients in the placebo group.
With sales in 2006 of $1.316 billion, up from $680 million in 2005, Cymbalta
is a promising driver of growth for Lilly. Despite the strength of this drug
the market, it has not been without its opponents. Detractors point to both
the exponential growth in the number of prescriptions for SNRIs in recent
years and the link that has been made between these drugs and a potential for
increased risk of suicide in children and teenagers. Cymbalta is not approved
for use in pediatric patients.
It is estimated that approximately 6.5 million Americans are diagnosed with
GAD each year. Many of those diagnosed will seek treatment in the form of
cognitive behavior therapy. However, because of the chronic nature of the
disorder and because GAD has been linked with irregular levels of
neurotransmitters in the brains of those affected, many individuals find they
are better able to manage the disorder with the help of pharmaceutical drugs.
Cymbalta's expanded indication is good news for adult patients and prescribers
who are looking for additional pharmaceutical options for the treatment of
generalized anxiety disorder and for Eli Lilly, which is counting on the drug
to prove to be a safe and effective treatment for a wide range of mental and
physician disorders related to serotonin and norepinephrine absorption.
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GSK hay fever drug relieves symptoms
A GlaxoSmithKline allergy medicine currently under review by the FDA, was
effective and well-tolerated in treating a range of nasal allergy symptoms
such as congestion, sneezing, itchy and runny nose, according to phase III
clinical studies.
In two separate phase III studies, fluticasone furoate nasal spray (FFNS) was
more effective than placebo in relieving both the nasal and eye symptoms of
patients 12 years and older with seasonal allergic rhinitis, commonly known as
hay fever.
One additional phase III study among individuals with perennial allergic
rhinitis (year-round nasal allergies) found FFNS to be more effective than
placebo in relieving nasal symptoms. Moreover, the symptom-relief lasted 24
hours in all three studies.
"These are the first two prospectively-designed phase III studies to
demonstrate consistent and significant improvement in eye-related allergy
symptoms with an intranasal steroid," commented lead investigator William
Lumry, Asthma & Allergy Specialists, Dallas.
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