Cerus Corporation (NASDAQ:CERS) has announced that the Food and Drug Administration has approved its Biologics License Application seeking authorization for the transportation of interstate distribution of pathogen-reduced platelets with the INTERCEPT Blood System.
Cerus made the announcement yesterday, revealing that the FDA has green-lit the company’s first Biologics License Application (BLA)). The latter sought authorization for the company to distribute pathogen-reduced platelets with the INTERCEPT Blood System across multiple states. Numerous additional health centers have also submitted their BLAs for approval by the FDA.
“The BLA approval is a key milestone for Cerus as it improves patient access to INTERCEPT Platelets. Rhode Island Blood Center now has the ability to ship INTERCEPT treated blood components across state lines to hospitals in regions where demand has exceeded supply due to various factors,” stated William “Obi” Greenman, the president and Chief Executive Officer at Cerus.
Lawrence Smith, the CEO of the Rhode Island Blood Center stated that the FDA authorization means they can now offer INTERCEPT treated blood components. Additionally, the components will not only be available in Rhode Island, but they will also be able to supply them across Southern New England with the help of the New York Blood Center network. The latter consists of associated blood centers. The approval also marks a significant step for the company as far as the availability of the solution is concerned.
Having the ability to distribute the INTERCEPT treatment blood components across state lines will also go a long way towards boosting access. This move is expected to play out well as far as satisfying the heavy demand from hospitals in various regions that were previously not served well.
Blood centers often have to go through the Biologics License Application procedure to seek FDA authorization to bring a biologic product into interstate commerce. They are usually restrictions preventing the INTERCEPT-treated products from being distributed to hospitals within the states where they are produced. This is why the BLAs are necessary. Some blood centers often end up distributing exclusively within the state where they operate but most of the blood centers have acquired extensive interstate delivery rights.
Cerus stock closed the latest trading session on Thursday at $3.05.