Plegridy (peginterferon beta-1a) was approved by the U.S. Food and Drug Administration (FDA) on August 18, 2014, making it available for prescription in the United States.
Plegridy is a medication specifically designed to treat relapsing forms of multiple sclerosis (MS). This includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults. Its approval marked a significant advancement in treatment options for individuals living with MS, offering a longer-acting interferon formulation that typically requires less frequent injections compared to previous interferon therapies.
The development and regulatory journey for Plegridy involved several key milestones in its path to market availability:
| Date | Event |
|---|---|
| Jul 19, 2013 | US and EU regulatory authorities accepted marketing applications for Plegridy for review. |
| Aug 18, 2014 | FDA approved Plegridy (peginterferon beta-1a) for the treatment of multiple sclerosis in the U.S. |
This FDA approval signifies that Plegridy was deemed safe and effective for its intended use based on comprehensive clinical trials. Following this approval, patients in the U.S. could then access this treatment through their healthcare providers. For more detailed information regarding its approval history and other related data, you can refer to reputable drug information resources.
