Exondys 51 stands out for more reasons than its unique and controversial status as the only Duchenne muscular dystrophy drug to make it through the regulatory gamut this year.
It was one of only three new drugs approved by the FDA in the last quarter, bringing the agency’s annual tally year-to-date to a mere 17. By this time last year, the agency had OK’d a roster of 28 new drugs, on its way to a generational high of 45 for the year.
But even with a 4th-quarter burst of approvals, it will be hard for the FDA to avoid seeing a sharp drop in the overall number of market approvals by end of the year, reversing a trend of rising market launches.
