logo
Share SHARE
FONT-SIZE Plus   Neg

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

BioMarin Pharmaceutical Inc. (BMRN) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Life expectancy at birth in the U.S. is already lower than most other developed nations and is now projected to fall further behind by 2030, according to a new study. It also suggests that by 2030, national female life expectancy in South Korea could break the 90 year barrier. Department store chain J.C. Penney Co. Inc. on Friday reported a turnaround to profit in the fourth quarter as a slight decline in sales was more than offset by lower expenses. Adjusted earnings per share for the quarter beat analysts' expectations, while revenues slightly missed their estimates. Earlier today, J.C. Penny announced a plan to optimize its national retail operations. Google is planning to significantly expand a carpool service on its navigational app Waze, according to a report in the Wall Street Journal. The move indicates the company is edging closer to a potential clash with ride-hailing service Uber Technologies Inc.
comments powered by Disqus
Follow RTT