November 30, 2023 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, provided an update after its recent consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval of its CardiAMPautologous cell therapy for the treatment of patients with ischemic heart failure of reduced ejection fraction (HFrEF).
Japan’s PMDA asked for further details on a number of elements included in BioCardia’s CardiAMP preclinical and clinical packages in order to gain approval. For the points raised with respect to the pre-clinical package, BioCardia management believes that these can be readily addressed. In the request for additional details with regard to the clinical package, PMDA has signaled that they would not require additional studies in Japan and could approve CardiAMP Cell Therapy based on data from overseas. PMDA indicated they would like to see detailed interim and the final results from the CardiAMP Heart Failure Trial, which has completed patient enrollment and is finishing up study patient follow-up visits. There was discussion that approval of any initial indication may be limited to patients with NT-pro BNP levels > 500pg/ml, which is an eligibility criterion for the CardiAMP Heart Failure II study as recently approved by the U.S. FDA. Formal minutes from the PMDA meeting are expected in four weeks and a follow-up consultation is being planned.
“We are thankful that PMDA has signaled that data from outside Japan is likely to be sufficient for approval” said Peter Altman, PhD., BioCardia’s President and Chief Executive Officer. “We continue to work with PMDA to demonstrate that the evidence of patient benefit with low risk from this minimally invasive autologous cell therapy for a life-threatening condition should be sufficient for approval. PMDA approval would enable physicians and patients to consider the CardiAMP cell therapy option alongside other cell therapy approaches for the treatment of heart failure already in clinical use in Japan requiring open heart surgical administration of the cells.”
For more information: www.biocardia.com