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News from the FDA Approvals through June 2003

This article provides information on the FDA approvals for Emend, West Nile ELISA Test, Cypher, Prilosec OTC, Fabrazyme, Iressa, Velcade, and FluMist. It includes details on their indications, studies, manufacturer, and important considerations.

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News from the FDA Approvals through June 2003

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  1. Pharmacophilic minutes News from the FDAApprovals through June 2003

  2. Emend (aprepitant) • March 26, 2003 • Approved for use in combination with other anti-nausea and anti-vomiting drugs for delayed N&V associated with initial and repeat courses of chemotherapy. • Novel site of action: NK1 receptor • PK: • Expected interactions with warfarin (CYP2C9) and OC. • Metabolized by CYP3A4 (main) and CYP1A2 (minor) • Studies: 2 trials with > 1000 patients • Manufactured by Merck • Website: http://www.emend.com

  3. West Nile ELISA test • July 9, 2003 • Test approved as aid in diagnosis of WNV in patients with clinical symptoms consistent with viral encephalitis/meningitis. • Sensitivity 90 - 99% • Specific testing needed for confirmation.

  4. Cypher (sirolimus-eluting coronary stent) • April 24, 2003 • Approved for angioplasty procedures to open clogged coronary arteries. • Review based on laboratory and animal tests and 2 clinical trials. • SIRIUS Study (US Study) • N = 1058, Cypher vs uncoated stent • At 9-months treated group with less repeat procedures: 4.2 vs 16.8% • Lower restenosis 8.9 vs 36.3% • Combined endpoints 8.8 vs 21% • RAVEL Study (outside US) • Cordis (J&J) • Website: http://www.cypherusa.com

  5. Prilosec OTC • June 20, 2003 • Approved for “frequent heartburn”. • Formulation: 20 mg delayed release • Taken before meals once daily for 14 days • Labeled for a single 2-week course not more often than every 4 months. • Drug interactions to discuss with patients: • Based on interaction with CYP2C19 and CYP3A4 • Warfarin, chlorazepate, quinolone antibiotics, ketoconazole, propranolol, quinidine, ticlopidine, phenytoin, methotrexate. • Consumer website: http://www.priloseconline.com/

  6. Fabrazyme (agalsidase beta) • April 24, 2003 • Approved for treatment of Fabry Disease • Orphan drug • Deficiency in alpha-galactosidase A • Agalsidase is human form of enzyme produced by recombinant DNA technology • Approval under accelerated mechanism based on blood vessel biopsies of treated patients • Genzyme Co. www.genzyme.com • Administered IV 1mg/kg every 2 weeks • Infusion reactions are frequent and can be severe. • Replagal is alpha-galactosidase A by Transkaryotic Therapies Inc

  7. Agalsidase alpha • Compare: use Micromedex • Micromedex on THR or Caregate

  8. Iressa(genfitinib) • May 5, 2003 • Approved as single agent treatment for advanced NSCLC • Accelerated approval • Mechanism of action not known • Developed to block stimulatory signals in cancer cells mediated by tyrosine kinase including EGFR • Large studies showed no benefit • Subset analysis suggested selected benefit. • “Third-line” drug for patients with no other options • Studies are on-going. • AstraZeneca • Website: http://www.iressa-us.com/

  9. Velcade(bortezomib) • May 13, 2003 • Approved for treatment of multiple myeloma under accelerated approval protocol. • Approved for patients who relapse after 2 prior treatments or are resistant to last treatment. • Study: 202 patients (188 evaluated). • 28% response rate. • Smaller study with similar results (54) • ADE: Nausea, fatigue, diarrhea, headache, neutropenia, anemia, fever, peripheral neuropathy.

  10. Velcade, cont. • Marketed by Millennium Pharmaceuticals • Millineum pharmaceuticals website • Boronic acid dipeptide

  11. Bortezomib, cont’d. Specific/selective inhibitor of 26S proteasome • Multicatalytic protease in all eukaryotic cells • Degrades proteins that have been conjugated to ubiquitin • Major mechanism for orderly intracellular protein degradation (80%) • regulatory proteins: cellular integrity, cell-cycle control, cellular apoptosis, transcription factor activation, and tumor growth • Exerts a dysregulating effect on these regulatory proteins, resulting in disruption of cell proliferation and apoptosis.

  12. FluMist(influenza virus vaccine, live) • June 17, 2003 • First nasally administered vaccine in US • First live influenza virus vaccine approved in US • Study: • 20,228 patients including 10,000 children. • Efficacy of 87% (pediatric) • For patients > 50 yo the “safety and efficacy has not been established”. • Not for use in people with chronic underlying conditions that may predispose them to severe flu. Use injected vaccine. • Made by Medimmune • Website http://www.medimmune.com/

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