Cinclus Pharma receives positive FDA feedback on CMC meeting
Cinclus Pharma Holding AB (publ), a late-stage clinical pharmaceutical company developing the next-generation treatments for acid-related diseases, today announced that it received positive feedback from a recent Chemistry, Manufacturing, and Controls (CMC) meeting with the U.S. Food and Drug Administration (FDA), supporting continued advancement of its lead product candidate, linaprazan glurate.
The FDA provided clear guidance and alignment with Cinclus Pharma’s proposed CMC strategy preparation for the upcoming new drug application (NDA) submission during the meeting. The agency did not raise concerns about the proposed strategy, reinforcing the company’s confidence in its manufacturing approach and regulatory preparedness.
“We are very encouraged by the outcome of the CMC meeting with the FDA. This feedback represents an important milestone in our regulatory journey and supports our commitment to advancing linaprazan glurate to patients as efficiently and safely as possible.”, says Christer Ahlberg, CEO at Cinclus Pharma.
The CMC meeting is a critical part of the regulatory pathway. During this meeting, the FDA evaluates whether the company’s activities and plans are suitable for establishing reliable manufacturing processes and quality control systems. In other words, it assesses the overall readiness to produce a drug consistently and safely. These meetings are designed to identify and resolve any potential issues early in the development process, ensuring that the drug meets the agency’s rigorous standards for quality and compliance.
The company remains on track with its development timeline and plans to continue close engagement with the FDA as the development continues.