Shire Limited has announced the availability of Intuniv extended release tablets in pharmacies across the US for the treatment of attention deficit hyperactivity disorder, or ADHD, in children and adolescents aged six to 17. Intuniv, a once-daily formulation of guanfacine, is the first and only nonscheduled alpha-2a receptor agonist approved for the treatment of ADHD. In clinical trials, Intuniv provided significant efficacy across the spectrum of ADHD symptoms that can be disruptive, such as being easily distracted, interrupting others, running around excessively, arguing with adults and losing temper. Once-daily Intuniv is now available in US pharmacies in four dosage strengths (1mg, 2mg, 3mg, and 4mg) and is marketed in the US by the existing Shire ADHD sales team of nearly 600 representatives.

Shire Limited announced the availability of INTUNIV(TM) (guanfacine) Extended Release Tablets in pharmacies across the United States for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents ages 6 to 17. INTUNIV, a once-daily formulation of guanfacine, is the first and only nonscheduled alpha-2A receptor agonist approved for the treatment of ADHD. In clinical trials, INTUNIV provided significant efficacy across the spectrum of ADHD symptoms that can be disruptive, such as being easily distracted, interrupting others, running around excessively, arguing with adults, and losing temper. INTUNIV has been shown to improve a range of ADHD symptoms and provides prescribers and patients with another treatment option for this complex disorder. The US Food and Drug Administration (FDA) approved INTUNIV on September 2, 2009. Once-daily INTUNIV is now available in US pharmacies in four dosage strengths (1 mg, 2 mg, 3 mg, and 4 mg) and is marketed in the United States by the existing Shire ADHD sales team of nearly 600 representatives. INTUNIV is not a controlled substance and has no known potential for abuse or dependence.

Shire Limited announced that the United States Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for velaglucerase alfa, the company's enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease. Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists, and accelerates the target review timing from ten to six months. The FDA has issued an action date for the NDA of February 28, 2010 under the Prescription Drug User Fee Act (PDUFA). In the U.S., patients continue to be enrolled in an FDA-approved treatment protocol, under Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase. This enzymatic deficiency causes an accumulation of glucocerebroside, primarily in macrophages. In this lysosomal storage disorder (LSD), clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, skeleton, and lungs. Velaglucerase alfa supplements or replaces beta-glucocerebrosidase, the enzyme that catalyzes the hydrolysis of glucocerebroside, reducing the amount of accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease.