Shots:

• The approval is based on the two trials i.e.- P-III Darvadstrocel-3002 & ADMIRE-CD trial evaluating the safety & efficacy of Alofisel in 22 & 212 patients with CPF with non-active/mildly active luminal CD
• The results from the P-III ADMIRE-CD trial showed that the proportion of patients in Alofisel over the control group achieved 1EPs of combined remission (51.5% vs 35.6%) @24wks. follow-up & maintained over 52wks. (56.3% vs 38.6%). The therapy was well-tolerated with a similar safety profile
• Alofisel is the first expanded human allogeneic adipose-derived MSCs to be approved in Japan. The therapy has received ODD in the EU in 2009 & RMAT designation from the US FDA in 2019

  Ref: Takeda | Image:Takeda