ViroPharma gets FDA backing for industrial scale Cinryze manufacturing

US biotech firm ViroPharma (Nasdaq: VPHM) says that the US Food and Drug Administration has approved the supplement to the Cinryze Biologics License Application (BLA) for industrial scale manufacturing changes. As previously announced, the company expects completion of labeling for previously produced vials to take around six weeks before entering into the trade.

"We believe the approval of our supplement for industrial scale manufacturing now enables us to ensure Cinryze is available to any patient who chooses prophylaxis against their attacks of hereditary angioedema," stated Dan Soland, ViroPharma's chief operating officer.

Mr Soland added: "With the addition of the industrial scale process to our current production, we believe we now have the means to ensure the market is fully served and build adequate safety stock levels. We also believe we have flexibility to increase our production even further through additional shifts should the need arise."