Drugs

Petition Seeks to Block Vigabatrin Exclusivity

Law firm Sidley has petitioned FDA on behalf of an unnamed client asking that it not grant orphan-drug exclusivity (ODE) to Pyros Pharmaceuticals’ vigabatrin oral solution (PYR-003), indicated for infantile spasms, unless Pyros can demonstrate that its version of vigabatrin is “clinically superior” to all previously approved versions.

Sidley argues in the petition that because an earlier version of vigabatrin had already enjoyed seven years of ODE for infantile spasms, a new period of ODE is only available if Pyros can “demonstrate clinical superiority through actual data substantiating increased efficacy, increased safety, or a major contribution to patient care.” The law firm says that there is no public record of any trial that could support a claim that PYR-003 is more effective than the existing vigabatrin product.

“Pyros also does not appear to be conducting any clinical trials or other studies comparing the safety of PYR-003 and any other vigabatrin product,” Sidley contends. “That alone should preclude Pyros from substantiating a greater safety claim.”

Additionally, Sidley says the Pyros’s vigabatrin cannot be seen as making a major contribution to patient care, and thus qualify for ODE. It says a recent patent declaration suggests that Pyros intends to include one or more flavoring or sweetening agents. “Adding a flavoring agent and/or sweetener to improve the taste of a medication cannot be a major contribution to patient care,” Sidley argues. “That pathway is reserved for ‘unusual cases.’” The law firm says the flavoring exception was intended to constitute a narrow category and was not intended to open the flood gates to FDA approval, adding that this type of minor change could be made to “virtually any oral medication.”

Sidley concludes that because there are no data demonstrating that PYR-003 provides greater efficacy, greater safety, or a major contribution to patient care, “it cannot be considered clinically superior to existing vigabatrin products.”

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