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| VPHM > SEC Filings for VPHM > Form 8-K on 4-Jun-2009 | All Recent SEC Filings |
4-Jun-2009
Other Events, Financial Statements and Exhibits
On June 3, 2009, ViroPharma Incorporated received a complete response letter
from the U.S. Food and Drug Administration (FDA) related to its supplemental
Biologics License Application (sBLA) for Cinryze™ (C1 esterase inhibitor
[human]) as a treatment for acute attacks of hereditary angioedema (HAE). The
FDA has requested an additional clinical study, due to their opinion that the
placebo controlled study submitted in support of the sBLA lacked robustness. The
full text of a press release issued by ViroPharma Incorporated in connection
with the complete response letter is set forth as Exhibit 99.1 attached hereto.
The following exhibits are attached to this Form 8-K:
(d) Exhibit No. Description
99.1 Press release dated June 4, 2009.
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