No Word from US FDA on Orphan Drug Exclusivity

December 1, 2022

Syringe with glass vials and medications pills drug

The US Food and Drug Administration (FDA) is maintaining silence after losing a case last year over exclusivity of an orphan drug. In the case, and appeals court ruled the agency was wrong in approving a rare disease drug that shared its main ingredient with an existing orphan drug with exclusivity. As the silence continues, industry leaders worry about orphan drug exclusivity going forward, especially with the impending drug pricing reform from the Inflation Reduction Act.

According to Zachary Brennan, “The agency made clear last May that the court’s decision would have a profound impact on rare disease drug development and in the way it assesses exclusivity as it “blocks approval of another company’s application for the same drug for the entire disease or condition for which the drug is granted orphan-drug designation, regardless of whether the drug was approved only for a narrower use or indication.””

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(Source: Endpoints News, December 1st, 2022)

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