This is the first ever approval of a gene therapy product in the US and hence an important milestone for gene therapy as such.
30 August 2017 is a historical day for gene therapy! FDA has just approved the first gene therapy for the US market. By approving Kymria from the pharmaceutical company Novartis for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL), they have demonstrated their confidence in the safety and efficacy of a gene therapy product.
This is most likely the first in a row of approved gene therapies we could expect over the nearest coming years – both in the US and Europe.
For further information:
CombiGene AB (publ)
Jan Nilsson, CEO
Phone: +46 (0)704 66 31 63