Shire says FDA extends review of marketing application for Elaprase by 90 days

By E. Janene Geiss

Philadelphia, May 17 - Shire plc said Wednesday that the Food and Drug Administration has extended by 90 days the review period for the Biologics License Application for Elaprase (idursulfase).

This extension will allow the FDA additional time to review data and analyses they recently requested during label discussions, according to a company news release.

Shire said the FDA advised the company Tuesday that the new action date for the application is Aug. 24.

"Shire will continue to work closely with the FDA during this brief extension of the Elaprase BLA review and through this cooperative effort we expect that Elaprase will be approved and launched by the third-quarter 2006," Matthew Emmens, chief executive officer, said in the release.

The U.S. application for Elaprase was submitted in November and was granted priority review, requiring the FDA to take action within six months.

A marketing authorization application for Elaprase has been submitted to the European Medicines Agency, and Shire said it expects a response on that application before the end of the year.

The drug has been developed for the treatment of Hunter syndrome, a serious genetic disorder, mainly affecting males, that interferes with the body's ability to break down and recycle specific chemicals called mucopolysaccharides, also known as glycosaminoglycans. Hunter syndrome is one of several related lysosomal storage diseases.

Shire is a Basingstoke, England, specialty pharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.