Drugs

Put Restrictions on Leqvio ANDA or NDA: Petition

Novartis is petitioning FDA to put restrictions on any ANDA or 505(b)(2) NDA citing Leqvio (inclisiran) as the reference-listed drug (RLD). The 11/18 petition says Leqvio is indicated as an adjunct to diet and exercise to reduce LDL cholesterol in adults with hypercholesterolemia. It says Leqvio contains the active ingredient inclisiran, a double-stranded small interfering RNA conjugated on the same strand with triantennary N-acetylgalactosamine to facilitate delivery to hepatocytes.

The petition says a 5/19/2023 FDA draft product-specific guidance for generic drug product development for inclisiran sodium stated that the diastereomeric composition of a test active pharmaceutical ingredient (API) should be compared to that of the API from the RLD. But, it says, the draft guidance was silent on how closely a test API must match the diastereomeric profile of inclisiran.

“When there is residual uncertainty as to the sameness of the diastereomeric profile, an in vivo study with pharmacodynamic endpoints should be required to confirm API sameness and to establish bioequivalence to the reference-listed drug,” the company says.

Novartis specifically asks that FDA:

refuse to approve any ANDA or any 505(b)(2) NDA referencing Leqvio as the RLD and seeking to rely on FDA’s previous finding of safety and efficacy unless the applicant demonstrates that the proposed product presents the same diastereomeric profile as the reference-listed product on both the sense and antisense strands and in the double-stranded product; and
refuse to approve any ANDA or 505(b)(2) NDA reference Leqvio as the RLD and seeking to rely on FDA’s previous finding of safety and efficacy unless the applicant demonstrates sameness of immunogenicity profiles.

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