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news.Ovation Pharmaceuticals, a biopharmaceutical company, has announced that Xenazine tablets, an orphan drug recently approved by the FDA for the treatment of chorea associated with Huntington's disease, is now available throughout the US.
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Xenazine is said to be the first and only FDA-approved treatment specifically developed for any Huntington’s disease (HD)-related symptom. Xenazine will be distributed throughout the US via a specialty pharmacy network.
This approach to distributing the medication is designed to both help streamline prescription fulfillment, as well as to provide specialized assistance to healthcare professionals, patients and caregivers, including addressing questions about the appropriate use of Xenazine, the company said.
Upon approval of Xenazine, the FDA determined that a risk evaluation and mitigation strategy (REMS) was necessary to ensure that the benefits of the drug outweigh the risks of depression and suicidality, to promote the informed prescribing and proper titration and dosing of Xenazine, and to minimize the risk of drug-drug interactions.
Also, as part of the program associated with the REMS, Ovation has begun the process of educating physicians, pharmacists, patients and their caregivers about the safe and effective use of the drug.
Jeffrey Aronin, president and CEO of Ovation, said: “The availability of Xenazine in the US represents a major advancement for the HD community that until now had no FDA-approved treatments specifically developed for this devastating disease.”