Please login to the form below

Not currently logged in
Email:
Password:

Shire's Replagal is fast-tracked by the FDA

Shire has received Fast Track designation from the FDA for its enzyme replacement therapy for Fabry disease, Replagal (agalsidase alfa)

Speciality biopharmaceutical company, Shire has received Fast Track designation from the FDA for its enzyme replacement therapy for Fabry disease, Replagal (agalsidase alfa).

Shire requested Fast Track designation at the suggestion of the FDA after the regulator requested additional data to back-up Shire's Biologics License Application (BLA), which the pharma company then withdrew.

Following its receipt of Fast Track approval, Shire will initiate the rolling submission of the Replagal BLA, and will submit the requested additional data later this year.

"We will continue to work closely with the FDA in the coming months on the rolling BLA submission for Replagal," said Sylvie Grégoire, president, Shire Human Genetic Therapies. "We remain committed to continuing to provide Fabry patients in the United States with Replagal under the treatment protocol."

Replagal is currently approved for the treatment of Fabry disease in 45 countries worldwide. The drug was made available to US patients in December 2009 through the Replagal early access programme, an FDA-approved treatment protocol, put in place as a result of the supply disruption of the only currently marketed treatment for Fabry disease in the US.

Fabry disease is estimated to affect between 8,000 and 10,000 people worldwide. The condition affects both men and women and can reduce lifespan by around 20 years in men and 15 years in women. Principal causes of death are renal failure, cardiomyopathy and cerebrovascular events such as stroke.

25th February 2010

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Branding Science

We are Branding Science Partners in thinking which inspires change in healthcare Branding Science are an award-winning global pharmaceutical market...

Latest intelligence

clinical research org
The important role of CROs in shaping the future of clinical research across Europe
Looking at the impact of COVID-19 on clinical research activities...
What’s in it for me? How to engage, motivate and support staff with internal training at OPEN Health
...
Environmental impact of in-person vs. virtual meetings
Although it will be tempting to resume in-person activities in the same capacity as before, we need to weigh the pros and cons of virtual vs. in-person vs. hybrid events...

Infographics