Despite a strongly critical complete response letter - which the FDA sent in August but did not make public until Tuesday - the drugmaker successfully appealed and won approval for the drug, Vyondys 53, in December, to the surprise of many.
The FDA had previously rejected Sarepta's application for Vyondys 53 in August, citing infections and kidney toxicity in preclinical studies. However, some analysts saw the move as a 'slap on the wrist' for the controversial approval of Sarepta's first DMD drug.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
In a note to investors, SVB Leerink analyst Joseph Schwartz suggested that the 'questionable' approval of Sarepta's Exondys 51 may have played a role in the FDA's decision to turn down golodirsen.
The decision stood in contrast with the agency's highly controversial approval of Sarepta's previous DMD drug, Exondys 51. The company's shares fell sharply in after-hours trading.