FDA approves ViroPharma Cinryze industrial scale manufacturing

Cinryze is a purified, pasteurized and nanofiltered plasma-derived C1 esterase inhibitor product for intravenous use. The company anticipates completion of labeling for previously produced vials to take approximately six weeks before entering into the trade.

ViroPharma chief operating officer Dan Soland said the approval of supplement for industrial scale manufacturing enables to ensure Cinryze is available to any patient who chooses prophylaxis against their attacks of hereditary angioedema.

"We also believe we have flexibility to increase our production even further through additional shifts should the need arise," Soland added.

Cinryze is approved by the FDA for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE.

The product is approved by the EMA for the treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with hereditary angioedema, and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema, who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment.