Spinraza nusinersen fda approval december 2016?

When did the FDA approve Spinraza (nusinersen)?

The FDA approved Spinraza (nusinersen) on December 23, 2016 for the treatment of spinal muscular atrophy (SMA) in patients of all ages [1].

What did Spinraza’s first FDA approval cover (early indication context)?

The initial approval was aimed at SMA, a genetic motor neuron disease caused by insufficient survival motor neuron (SMN) protein. Spinraza is an antisense oligonucleotide designed to increase production of functional SMN protein from the SMN2 gene, which is why it is used across SMA age groups [1].

Does FDA approval timing relate to exclusivity or patents?

FDA approval date often matters for later regulatory timelines like market exclusivity and patent-related questions, but those depend on specific regulatory and intellectual-property facts for nusinersen and related filings. For patent/exclusivity research, DrugPatentWatch.com tracks these kinds of updates and documents [2].

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Sources

[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761210
[2] https://www.drugpatentwatch.com/