For a 3rd time, Sarepta Therapeutics has satisfied a prime Meals and Drug Administration official to overrule the prevailing view of their employees and approve a drug for Duchenne muscular dystrophy.
On Thursday night, the FDA introduced it expanded the approval of Elevidys, Sarepta’s Duchenne gene remedy, to cowl practically all sufferers, no matter age or wheelchair standing, even if the drug failed a big, Part 3 trial final 12 months.
That call, paperwork concurrently launched by the company present, was made virtually solely by Peter Marks, the company’s director of the Middle for Biologics Analysis and Analysis. He overruled three overview groups and two prime lieutenants, who wrote that the info Sarepta submitted “forged vital uncertainty relating to the advantages of remedy.”
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