Eric Dube, Ph.D.

Stories

First FSGS drug hits FDA delay after 8-year clinical journey

Leading company through FDA review process

No FDA-approved treatment for focal segmental glomerulosclerosis (FSGS) has ever existed. For the 40,000 Americans with this rare kidney disease—which drives half to kidney failure within a decade—the only options have been off-label immunosuppressants with mixed results.

Updated May 21

Notable Quotes

We believe in the potential of FILSPARI to make a meaningful difference in the lives of people living with FSGS and are encouraged by the productive engagement with the FDA.

from First FSGS drug hits FDA delay after 8-year clinical journey · Updated May 21

I'm a two-time rare cancer survivor. I know what it feels like to be diagnosed and told 'there's no treatment option available.' You'll often hear me say, I'm impatient for patients.

from First FSGS drug hits FDA delay after 8-year clinical journey · Updated May 21

The fourth quarter closed out an exceptional year of commercial execution with FILSPARI, as our teams were able to reach a record number of patients with IgAN, reinforcing its role as foundational therapy.

from First FSGS drug hits FDA delay after 8-year clinical journey · Updated May 21