Transcript News from the FDA

News from the FDA
Approvals through June 2003
Emend (aprepitant)
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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)
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Studies: 2 trials with > 1000 patients
Manufactured by Merck
 Website: http://www.emend.com
West Nile ELISA test
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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.
Cypher
(sirolimus-eluting coronary stent)
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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)
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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)
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Cordis (J&J)
Website: http://www.cypherusa.com
Prilosec OTC
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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.
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Drug interactions to discuss with patients:
 Based on interaction with CYP2C19 and CYP3A4
 Warfarin, chlorazepate, quinolone antibiotics, ketoconazole,
propranolol, quinidine, ticlopidine, phenytoin, methotrexate.
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Consumer website: http://www.priloseconline.com/
Fabrazyme
(agalsidase beta)
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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
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Administered IV 1mg/kg every 2 weeks
Infusion reactions are frequent and can be severe.
• Replagal is alpha-galactosidase A by Transkaryotic Therapies Inc
Agalsidase alpha
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Compare: use Micromedex
 Micromedex on THR or Caregate
Iressa
(genfitinib)
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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
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Large studies showed no benefit
Subset analysis suggested selected benefit.
 “Third-line” drug for patients with no other options
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Studies are on-going.
AstraZeneca
Website: http://www.iressa-us.com/
Velcade
(bortezomib)
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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)
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ADE: Nausea, fatigue, diarrhea, headache, neutropenia,
anemia, fever, peripheral neuropathy.
Velcade, cont.
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Marketed by Millennium Pharmaceuticals
 Millineum pharmaceuticals website
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Boronic acid dipeptide
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
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Exerts a dysregulating effect on these regulatory proteins,
resulting in disruption of cell proliferation and apoptosis.
FluMist
(influenza virus vaccine, live)
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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”.
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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/