Sequana Medical Announces Positive FDA Day 100 Meeting Outcome for Alfapump PMA Application

Sequana Medical, a leading innovator in treatments for fluid overload in liver disease, heart failure, and cancer, has announced a successful outcome from its "Day 100" meeting with the US Food and Drug Administration (FDA) regarding its Premarket Approval (PMA) application for the alfapump® system. The device, designed for patients suffering from recurrent or refractory ascites due to liver cirrhosis, is fully implantable and wirelessly charged, offering a breakthrough alternative to traditional treatments.

The PMA application for the alfapump was initially accepted for substantive review on January 29, 2024. Following FDA's review, a "Day 90" major deficiency letter was issued, and a subsequent "Day 100" meeting was convened to address key issues. The FDA confirmed that the substantive review was complete and indicated no further new questions on clinical or pre-clinical data, apart from those related to the Company's response to the "Day 90" letter. Some non-clinical questions remain, requiring additional work, and the Company plans to submit this supplementary information by the end of September 2024.

In view of the FDA's feedback and evolving cybersecurity concerns, Sequana Medical has decided to exclude RPMS/DirectLink software from its initial PMA application and commercialization plans for the alfapump. Instead, a next-generation version will be submitted post-approval as a PMA supplement. This adjustment does not alter the anticipated timeline for FDA approval, which is now forecasted for Q1 2025, nor the planned US commercial launch set for the second half of 2025.

Timur Resch, Global Vice President of QM/QA/RA at Sequana Medical, expressed enthusiasm over the developments, noting the significant progress made and the Company's commitment to addressing the remaining questions promptly. Ian Crosbie, CEO of Sequana Medical, also emphasized the importance of the collaborative discussions with the FDA and the clarity gained on the path to approval.

The alfapump is seen as a potential game-changer for treating recurrent or refractory ascites, a condition where fluid accumulates in the abdomen, making current treatments like therapeutic paracentesis cumbersome and invasive. The device aims to automatically and continuously remove ascites and has shown promising results in the POSEIDON study, which was pivotal to the PMA application. Conducted across 18 centers in the US and Canada, the study involved 69 patients and demonstrated statistically significant effectiveness and safety endpoints at six months post-implantation.

The study also highlighted the alfapump's ability to virtually eliminate the need for therapeutic paracentesis and significantly improve patients' quality of life. Further data at 12 months post-implantation reinforced these findings. Additional analyses, including a patient preference study and a matched cohort analysis with the NACSELD-III registry, indicated a strong preference for the alfapump over standard paracentesis and comparable safety profiles.

The market potential for the alfapump in North America is considerable, with the number of patients suffering from recurrent and refractory ascites expected to grow significantly due to the rising prevalence of non-alcoholic steatohepatitis (NASH). By 2025, the market is estimated to include around 78,000 patients, potentially expanding to 147,000 by 2032. Sequana Medical projects the total market opportunity to be approximately $2.4 billion by 2025, with $600 million coming from patients requiring frequent paracentesis.

Sequana Medical, headquartered in Ghent, Belgium, remains committed to pioneering treatments for diuretic-resistant fluid overload, which poses severe health challenges and significant economic burdens on healthcare systems. The Company's efforts extend beyond the alfapump to include DSR® therapy, aimed at breaking the cycle of cardiorenal syndrome in heart failure patients, with ongoing clinical studies showing promising results.

As Sequana Medical advances towards FDA approval and commercial launch of the alfapump, it continues to explore financing options to support these critical milestones, reaffirming its dedication to improving patient outcomes and quality of life.

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