This past December, the FDA issued a Complete Response Letter to drug manufacturer Sanofi in response to Sanofi's application seeking approval for Tolebrutinib, the first in a new category of investigational disease-modifying therapies to undergo FDA review.
A Complete Response Letter is an official letter from the FDA to a drug manufacturer stating that the agency can't approve a new medicine in its current form. It's not an outright “no” that kills a project; it's more like a “not yet.” However, this Complete Response Letter raised some issues which, at first glance, don't appear to be easily fixable.
Sanofi has pointed out that the issues raised in the Complete Response Letter were markedly different from the guidance they received from the FDA over the course of this approval process. Sanofi has also indicated that it would work with the FDA to find a path forward for Tolebrutinib.
Dr. William Conte, an MS Specialist and a principal investigator in the Phase 3 clinical trial for Tolebrutinib, has published an article responding to the FDA's Complete Response Letter. This week, Dr. Conte joins me to discuss the FDA's action and his response to that action.
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The FDA's Complete Response Letter about Tolebrutinib 1:09
Dr. William Conte responds to the FDA's Complete Response Letter 4:09
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RealTalk MS Episode 440
Guests: Dr. William Conte
