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Friday, Apr 19, 2024

FDA Approves Amgen’s Platelet Drug

The Food and Drug Administration has approved Nplate, a drug Amgen developed to produce platelets in those with low amounts of the substance in their blood. Although the FDA approved the drug, Amgen plans to study Nplate’s long-term efficacy and safety for the next three years. In addition, the Thousand Oaks company will launch Network of Experts Understanding and Supporting Nplate and Patients, a multi-faceted program designed to provide comprehensive access, support and education for patients, their caregivers and healthcare providers, according to the company. The network is part of the risk evaluation and mitigation strategy developed by Amgen in partnership with the FDA to assure safe use of Nplate while minimizing risk, Amgen explained. Through the program, eligible patients who are uninsured, underinsured, or unable to afford insurance co-payments may receive reimbursement support and other assistance from Amgen.

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