Since becoming law earlier this month, the breakthrough therapy designation has been granted to 24 of 67 requests received by the FDA. Pharmaceutical companies that have received the designation expect a much quicker approval for their products, according to the report.
Jay Siegel, MD, head of global regulatory affairs at Johnson & Johnson, expects the designation will take two years off the approval process for the company’s experimental cancer drug, ibrutinib, according to the report.
Jeffrey Leiden, MD, PhD, CEO of Vertex Pharmaceuticals, said the designation has been making the approval process for Kalydeco, a cystic fibrosis drug, “immeasurably smoother,” according to the report.
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