FDA wants another study of ViroPharma

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The news sent ViroPharma shares 8 percentg lower Thursdayto $6.35. The Exton, Pa., biopharmaceuticaol company is seeking to get Cinryzee approved as a treatment for hereditary angioedema (HAE), a rare and life-threatnenin g condition that causes swelling in variousz body parts including the feet, face and throat. The drug is already approved for use in preventintg hereditaryangioedema attacks. The FDA told ViroPharma VPHM) Thursday that the placebo-controlled studg submitted in support of theapplication “lackedr robustness.
” "Though Cinryze is already successfully preventing attacks of HAE in many there remains an unmet medical need for patientws suffering from acute laryngeal attacks," said Vincenrt Milano, ViroPharma's president and CEO. "Despiter having a statistically significant result using the mostconservativwe intent-to-treat analysis, the FDA feels that the data are not robustg enough to support approval at this We intend to responrd to the FDA about our and we will provide an update on the second-quarter financial ViroPharma acquired the product last year when it bough Lev Pharmaceutical s of New York.
The FDA did approve patient labelinhg for Cinryze toincludr self-administration for routine prevention of HAE once patients are properlyu trained by their health-care provider. Patients with HAE experienc e about 20 to 100 days of incapacitationmper year. Health officials estimat about 6,000 people in the United Stateshave HAE.