Avrobio retools Fabry gene therapy plans after competing drug's full approval shuts pathway to an accelerated nod
It’s been a long road for lentiviral gene therapy player Avrobio in the rare lysosomal disorder Fabry disease after early data sent investors running for the hills back in 2018. Right on the heels of a promising readout, Avrobio will now tinker with its regulatory plans for that therapy after the FDA flipped the script and handed a competing drug an unlikely full approval.
The biotech will rejigger its development plans for AVR-RD-01, an investigational gene therapy for Fabry disease, after the FDA granted a full approval to Sanofi’s enzyme replacement therapy Fabrazyme back in March, validating a new kidney biopsy surrogate endpoint Avrobio now hopes to pursue, the company said Monday.
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