Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

BioMarin Pharma: FDA Accepts Vimizim BLA And Grants Priority Review Designation

RELATED NEWS
Trade BMRN now with 

BioMarin Pharmaceutical Inc. (BMRN: Quote) announced that the U.S. Food and Drug Administration or FDA has accepted for review the Biologics License Application or BLA for Vimizim (BMN-110, elosulfase alfa), an enzyme replacement therapy under evaluation for the treatment of patients with the rare lysosomal storage disorder Mucopolysaccharidosis Type IVA or MPS IVA, also called Morquio A Syndrome.

The company said that the FDA has granted priority review designation to Vimizim, which is granted to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. During the initial review of the application, the FDA requested additional Chemistry, Manufacturing and Controls or CMC information.

The company provided the information as requested, and the FDA designated it as a major amendment to the application thus extending the PDUFA action date by three months. The extended PDUFA action date is February 28, 2014.

In the FDA's filing communication, the Agency informed the company that it is currently planning to hold an advisory committee meeting to discuss the application. No date has been set for this meeting.

Click here to receive FREE breaking news email alerts for Biomarin Pharmaceutical Inc. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
In a surprise move, the Senate voted Tuesday to make changes to an important House highway funding bill, raising questions about whether the legislation will receive final approval before lawmakers leave town for the August recess. Stocks have given back some ground over the course of the trading day on Wednesday after failing to sustain an early upward move. The choppy trading reflects uncertainty ahead of a highly anticipated announcement from the Federal Reserve. After reporting a notable contraction in U.S. economic activity in the first quarter, the Commerce Department released a report on Wednesday showing that gross domestic product rebounded by more than anticipated in the second quarter.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.