Will Jazz Pharmaceuticals
In August, an advisory panel of outside experts voted 20-2 against approving Rekinla for fibromyalgia, so an FDA approval seems fairly unlikely. If fibromyalgia were a life-threatening disease without any treatment options, the agency might go against the panel's advice, but Pfizer's
The saving grace for investors will likely come in what the agency says Jazz needs to do to get the drug approved. Here are some things to look for.
A name change. Jazz sells the same drug as a narcolepsy treatment under the brand name Xyrem. The company proposed selling the drug as Rekinla for fibromyalgia, but based on advisory panel comments, the FDA will likely want to stick with Xyrem to avoid potential double prescriptions for narcoleptics with fibromyalgia. The issue seems ridiculous to me. We don't worry about depressed smokers getting double doses by taking GlaxoSmithKline's
More restrictive distribution. The active ingredient in Xyrem/Rekinla is related to the "date rape" drug GHB, which led to the FBI having a seat on the advisory panel. Because there are more potential prescriptions for fibromyalgia than narcolepsy, the agency wants to make sure the drug won't fall into the wrong hands. A more restrictive Risk Evaluation and Mitigation Strategies (REMS) will likely be required to make sure the right patients get the drug, which would typically trigger a six-month review after Jazz resubmits.
More clinical trials. The drug's efficacy doesn't seem to be in question, but some panel members seemed worried about the safety of the drug. If the FDA wants new trials, Jazz's hopes for increasing sales will be delayed significantly.
The first two seem like near-certainties to me, with the third being a bit of a wild card. I'd guess no new trials, but investors still have to factor it in as a possibility.
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