Regulatory
Heading into the first week after Memorial Day, which in the U.S. marks the typical beginning of summer, the U.S. Food and Drug Administration has a number of drug approvals on the calendar. Here’s a look.
“Today’s approval of Kynmobi advances treatment options for people with Parkinson’s disease who experience OFF episodes and the associated disruption of everyday activities,” said Antony Loebel, Sunovion’s president and chief executive officer.
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Clovis Oncology’s Rubraca remained the only PARP inhibitor approved for prostate cancer for only a handful of days. Today, that medication is joined by AstraZeneca’s and Merck’s powerhouse PARP inhibitor, Lynparza.
Research conducted under the collaboration will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns through the use of relevant and new data sources.
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The approval was based on interim analysis from the company’s Phase III IMpower110 trial.
With the new approval, Rubraca becomes the first PARP inhibitor approved in a prostate cancer setting.
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