Drug Topics - March 17, 2008 - (Page 8)

8 DRUG TOPICS MARCH 17, 2008 www.drugtopics.com > > > NEWS Roundup Rx Care Orphan drug Arcalyst debuts for two rare inflammatory diseases Orphan drug-designated rilonacept (Arcalyst injection), an interleukin-1 blocker from Regeneron Pharmaceuticals, has received approval from the Food & Drug Administration. The new therapy is indicated for the treatment of two Cryopyrin-Associated Periodic Syndrome (CAPS) disorders – Familial Cold Auto-Inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), both chronic inflammatory diseases. Rilonacept inhibits the action of interleukin-1, a signaling protein that regulates inflammatory processes and is present in excess in both FCAS and MWS patients. The approval was based on a clinical study that utilized a patient questionnaire to rate five signs and symptoms of CAPS – joint pain, fever/chills, rash, eye redness/pain, and fatigue. Patients treated with rilonacept noted an onset of relief of symptoms within several days of initiating therapy and experienced an improvement in overall symptom scores compared with those receiving placebo that was sustained throughout treatment. The inherited disorders affect approximately 300 people in the United States and are associated with a gene mutation in the CIAS 1 gene. Regeneron said the new product will be launched within 30 days of approval. turer of FluMist , the live attenuated nasal spray version of the vaccine, said it will ramp up production of its product to 12 million doses for next season in anticipation of the increased need. Pediatric indication granted to Nexium AstraZeneca has received word from the Food & Drug Administration that it may begin marketing esomeprazole (Nexium) for use in children ages one to 11 years for the short-term treatment of gastrointestinal reflux disease (GERD). Both the delayed-release capsule and the liquid formulations have been approved for the new indication. Approved dosing of the proton pump inhibitor is 10 mg to 20 mg per day for children one to 11 years of age and a 20- to 40-mg daily dose for adolescents 12 to 17 years old. Recombinant Factor VIII gets FDA nod Xyntha , from Wyeth Pharmaceuticals, a genetically engineered version of Factor VIII, was recently granted approval by the Food & Drug Administration for the control and prevention of bleeding in patients with hemophilia A. The antihemophilic factor product is manufactured using recombinant DNA techniques with genes from Chinese Hamster Ovary cells that are modified to produce Factor VIII. According to Wyeth, the culture in which the cells are grown is free of any human or animal material, and is plasma- and albumin-free, which minimizes the risk of infection. During drug studies, two of 89 patients who underwent 50 days of treatment with Xyntha developed Factor VIII inhibitors, antibodies that counteract treatment. The most frequently reported side effect was headache. When the product was used during surgery, the most common adverse reaction was fever. CDC expands recommended pediatric age range for influenza vaccine The CDC’s Advisory Committee on Immunization Practices (ACIP) has unanimously voted to expand the recommended age range for annual influenza immunization to include all children six months of age to 18 years old. The vote was taken at an agency meeting in Atlanta in February and will increase the number of children needing the vaccine by about 30 million. The CDC said the change should be implemented as soon as possible, but no later than the 2009-2010 flu season. In the interim, providers should begin efforts to immunize the new age group during the 2008-2009 season. Data were also presented at the meeting that emphasized the need for children under nine years of age, who are receiving the influenza vaccine for the first time, to receive two doses in order to provide sufficient protection. The National Foundation for Infectious Diseases’ Childhood Influenza Immunization Coalition (CIIC) said it supported the move to an expanded age range and hopes it will encourage Americans to get the annual flu vaccine as soon as it becomes available in their communities each year. MedImmune , manufac- Post-marketing liver injury reports lead to Tysabri PI update Reports of markedly elevated serum hepatic enzymes and elevated total bilirubin in patients receiving natalizumab (Tysabri, Biogen Idec/Elan) have prompted the manufacturers to update the Warnings and Precautions sections of the package insert. The elevated levels occurred as early as six days after the first dose of natal- Photo: Jim Shive http://www.drugtopics.com http://www.flumist.com http://www.xyntha.com http://www.xyntha.com http://www.cdc.gov/vaccines http://www.medimmune.com

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Drug Topics - March 17, 2008 Contents Commonly Confused Drug Pairs Medicaid Prescription Reimbursement Information By State ACP Issues Guidance On Optimal HbA1c for Type 2 Diabetics Latest News Roundup

Drug Topics - March 17, 2008

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