Not Jazzed About Xyrem REMS, Irish Company Begins Dispute Resolution
This article was originally published in The Pink Sheet Daily
Jazz will begin dispute resolution with FDA regarding the risk evaluation and mitigation strategy for its best-selling wakefulness drug.
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FDA approves a Risk Evaluation & Mitigation Strategy for Jazz Pharmaceutical’s Xyrem under protest; the agency says the single-pharmacy distribution plan for the narcolepsy treatment has the potential to block generic competitors from the market. FDA and Jazz had been working for seven years to agree to a REMS that confirms to the requirements under the FDA Amendments Act of 2007.
Single-pharmacy distribution system for Jazz’s narcolepsy treatment isn’t necessarily needed, FDA says, even as it clears that risk management plan.
The two biotech companies have teamed up to create a follow-on product to Jazz’s narcolepsy drug, a collaboration that could add to the patent-life of Xyrem and be financially beneficial for both companies.