Pink Sheet is part 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

UsernamePublicRestriction
UsernamePublicRestriction

Action Letter For Lev’s Cinryze Opens Window For Jerini To Hit Market First

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lev Pharmaceuticals received a "complete response" letter from FDA on its BLA for the C1-esterase inhibitor Cinryze for hereditary angioedema, giving German drug maker Jerini an opportunity to be first to market with a treatment for the orphan disease

You may also be interested in...



CSL Behring Submits C1-INH For Hereditary Angioedema

C1-esterase inhibitor joins Jerini's Firazyr and Lev's Cinryze in race to gain orphan exclusivity for acute HAE, and block other entrants

CSL Behring Submits C1-INH For Hereditary Angioedema

C1-esterase inhibitor joins Jerini's Firazyr and Lev's Cinryze in race to gain orphan exclusivity for acute HAE, and block other entrants

Lev’s Hereditary Angioedema Agent Cinryze Could Reach Market In Early 2008

The latest "ultra-orphan" compound to reach FDA is Lev Pharmaceuticals’ C1-esterase inhibitor Cinryze for the acute treatment of hereditary angioedema. Lev submitted the biologic July 31.

Topics

UsernamePublicRestriction

Register

PS003755

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

Cancel