FDA requests technical updates for Biogen's high dose nusinersen application

Biogen Inc. (NASDAQ: BIIB) received a Complete Response Letter from the U.S. Food and Drug Administration regarding its supplemental New Drug Application for a high dose regimen of nusinersen to treat spinal muscular atrophy.

The FDA requested an update to technical information in the Chemistry Manufacturing and Controls module of the application. The letter did not cite deficiencies in the clinical data for the high dose regimen, according to a company statement.

The FDA provided options for resolution, and Biogen plans to resubmit the application promptly based on readily available information.

"While this outcome was unexpected, we remain committed to bringing the high dose regimen to people living with SMA," said Priya Singhal, Head of Development at Biogen. "We are working diligently to provide the necessary information to the FDA."

The high dose regimen of nusinersen, marketed as SPINRAZA, was recently approved in Japan and is under review by the European Medicines Agency and other global regulators, the company stated.

SPINRAZA is currently approved in more than 71 countries to treat spinal muscular atrophy in infants, children and adults. More than 14,000 individuals have been treated with the drug worldwide, according to Biogen.

Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals Inc. (NASDAQ: IONS).

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