Cerus' proposed modular premarket approval (PMA) application shell for Intercept Blood System for platelets has been accepted for review by the US Food and Drug Administration (FDA).
The PMA application shell accepted by the FDA for the platelet system provides for three modular submissions.
Under a modular approach, the FDA reviews each module separately and provides applicant with timely feedback and potentially resolve deficiencies earlier in the review process.
The first module is scheduled for submission at the end of September 2013.
Cerus regulatory affairs, quality and clinical senior vice president Carol Moore said the platelet PMA shell proposal was designed to leverage synergies with the company’s ongoing modular PMA submissions for plasma system, allowing for target completion of all three platelet modules by March 2014.
"With the scheduled submission of the final INTERCEPT plasma module planned for the fourth quarter of this year, we have the possibility of receiving U.S. approvals for both products as soon as the second half of 2014," Moore added.
Cerus president and CEO William ‘Obi’ Greenman said the platelet PMA submission timeline accepted by the FDA means the company may be able to launch Intercept platelets and plasma virtually simultaneously in the US.
"Cerus is focused on succeeding at this goal, and maximizing the global impact we believe a U.S. market entry can create," Greenman added.