Cell Therapy plans a conditional authorisation for Heartcel for heart regeneration
Cell Therapy Ltd (CTL), a development stage biotechnology company with a portfolio of allogeneic regenerative medicines in clinical trials, announced that, following a pre-submission meeting with the European Medicines Agency (EMA) in September, CTL will begin the application process for a conditional marketing authorisation (CMA) for Heartcel, the first allogeneic stem cell therapy to regenerate the human heart, in Europe. Filing is planned for mid-2016, and, if successful, approval could be granted as early as 2017.
Conditional marketing authorization in the European Union may be granted by the EMA ahead of a final confirmatory clinical trial for a product for a life-threatening or serious debilitating disease with a high unmet medical need and where the benefits outweigh the risks.
Comment: In data published in June and September 2015, Heartcel demonstrated average two year MACE-free survival for all patients in a Phase II clinical trial studying myocardial regeneration.
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