NATURE BIOTECHNOLOGY
VOLUME 34 NUMBER 7 JULY 2016 p675
The first generation of exon-skipping drugs for Duchenne muscular dystrophy (DMD) has reached a critical juncture, as an FDA decision on whether to grant accelerated approval to Sarepta Therapeutics’ controversial drug Exondys (eteplirsen) looms. A rival effort at BioMarin Pharmaceutical, of San Rafael, California, is now over. Biomarin withdrew a European application for Kyndrisa (drisapersen) on May 31, after unsuccessful talks with European Medicines Agency officials, and the US Food and Drug Administration (FDA) refused to approve the same drug in January.
The refusals were unequivocal—drisapersen was neither safe nor effective. In the case of Sarepta’s eteplirsen, however, regulatory uncertainty abounds. The Cambridge, Massachusetts–based biotech, is seeking approval with evidence from just 12 patients. “In any other therapeutic area, the agency would be within its rights to
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