Pink Sheet is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


ViroPharma Gets Good News And Bad News On Cinryze From FDA

This article was originally published in The Pink Sheet Daily

Executive Summary

sBLA for acute angioedema treatment gets a “complete response,” putting Cinryze into the losers’ bracket contesting for the first U.S. acute HAE approval. Drug’s prophylactic labeling, meanwhile, is amended to allow self-administration.

Related Content

ViroPharma Talks Cinryze Sales, EU Launches
Dyax Kalbitor Is Third To Market For HAE, But First For All Acute Attacks
Berinert Claims Another Part Of The HAE Orphan Market, But May Leave Room
ViroPharma Looks To Cinryze To Drive Sales As Vancocin Faces Likely Generic Competition
Dyax Readies HAE Therapy Kalbitor For Launch; Awareness Precedes Approval
Dyax Receives “Complete Response” For HAE Drug; REMS Will Be Required
Dyax Receives “Complete Response” For HAE Drug; REMS Will Be Required
ViroPharma Sees Silver Lining In Maribavir Failure: Now There’s Cash To Go Bargain Hunting
Cinryze Prophylaxis Approval Leaves Window For HAE Treatment Contenders
Jerini’s Icatibant Falters in U.S., Wins In Europe





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts