Novartis Gambles Priority Review Voucher On Ilaris Gout Indication
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Sponsor preferred a tropical disease voucher because it could be redeemed for a supplemental application, but the FDA awarded a voucher under the medical countermeasures program, which prohibits redemption for supplements; agency says it takes a case-by-case approach to deciding whether tropical disease and rare pediatric disease vouchers can be redeemed for supplements.
Stakeholders are sympathetic to FDA's concerns that voucher program requires diversion of precious resources, but some believe it provides substantial drug development incentive, particularly for small companies.
FDA’s Anti-Infective Drugs Advisory Committee will review J&J’s product, a diarylquinolone, for the treatment of multi-drug resistant pulmonary tuberculosis on Nov. 28.