BIG NEWS: Drug up for FDA Approval for NF1 Plexiforms
Big news just hit…though it has been expected!
Many of us have been following the success of the drug selumetinib in treating people with neurofibromatosis and plexiform tumors and it was just announced that AstraZeneca and Merck & Co., Inc. has now applied to the US Food and Drug Administration (FDA) for approval of the drug for this use. This applications was given a priority review designation which means that the FDA’s goal is to take action on an the application within 6 months (compared to 10 months under standard review). The application presents selumetinib “as a potential new medicine for pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs).”
While this is a big step, it’s not the end of the process. If approved, there may still be obstacles in who can get it, insurance coverage, and more. We’ll do our best to keep our community posted!
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