Improving the efficacy and safety of Skyclarys in FA patients
Sub Subramony, MD, describes the ongoing efforts to assess and improve the efficacy and safety profile of Skyclarys now that it’s been released to a broader demographic than what was represented in clinical trials.
About Sub Subramony, MD
Sub Subramony, MD, is a board-certified neurologist and neuromuscular medicine specialist at the Norman Fixel Institute for Neurological Diseases at University of Florida Health. He also serves as a professor in the University of Florida Department of Neurology with a joint appointment in pediatrics. His area of focus is genetic neuromuscular diseases, including Friedreich’s ataxia.
Transcript
Yes, I mean, I think with the introduction of omaveloxolone in the real world, it’s important that we continue to monitor their safety profile as per instructions from the pharmaceutical company and report any particular concerns back to the company for continued monitoring, post-marketing monitoring of this drug.
And certainly the patients who are going to be exposed to this drug now are a little bit wider in terms of their disease severity, et cetera, compared to what was done in the trial. So the trial was limited to a small number of patients with a fairly restricted — though it was still quite wide, you know, patients had anywhere from able to walk to wheelchair bound in the trial.
David Lynch, MD, PhD, is the director of the Friedreich’s Ataxia Program at Children’s Hospital of Philadelphia.