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

Two botulinum toxin BLAs become one approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's April 30 approval of Ipsen's botulinum neurotoxin type A complex reunited therapeutic and cosmetic indications that the company had pursued separately. Ipsen kept the therapeutic use (treatment of cervical dystonia) for itself and licensed cosmetic use for wrinkles, or glabellar lines, to Medicis. The cervical dystonia use was submitted as Dysport and the glabellar lines BLA was submitted as Reloxin in late 2007. The BLAs followed different paths before FDA converted Reloxin into an efficacy supplement under the Dysport (abobotulinumtoxinA) BLA - and united the products under the Dysport name - for approval. The review appears to have been marked by risk management issues: a user fee extension so FDA could review a risk communication plan was followed by a Dec. 29, 2008, "complete response" letter requesting a REMS. The BLA itself was also an issue: FDA refused to file Reloxin in late 2007 due to administrative issues; it was resubmitted March 12, 2008. FDA later extended the user fee goal from January 2009 to April 13, 2009

You may also be interested in...



Regeneron’s COVID-19 Antibody Cocktail Shows Early Promise, But Does It Merit An EUA?

Data from the first 275 patients in the trial are promising, but outside experts say they are wary of another hasty Emergency Use Authorization.

EU Regulatory Roundup, September 2020: Uncharacteristically Slow As COVID-19/Brexit Wreak Havoc

European Commission medtech news all but dried up in September. But the UK’s Brexit news and implications for medtech has given EU and UK medtech stakeholders enough to ponder.

ESMO: BMS’s Opdivo Edges Merck & Co’s Keytruda In First-Line Advanced Gastroesophageal Cancers

A new frontier for IO therapies in gastric/gastroesophageal cancers is opening up on positive data for two leading checkpoint inhibitors in first-line advanced disease where BMS’s Opdivo looks likely to have an advantage over Merck & Co’s Keytruda.

Topics

UsernamePublicRestriction

Register

LL1134044

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