Sarep­ta CEO dis­putes FDA re­venge nar­ra­tive; Take­da posts long-term da­ta on key Shire drug

→ Sarep­ta hasn’t been hav­ing its best days with the FDA, but the biotech is keen to stay on the agency’s good side. Push­ing against a per­cep­tion that its sec­ond Duchenne mus­cu­lar dy­s­tro­phy ther­a­py, Vyondys 53, was re­ject­ed in an act of reg­u­la­to­ry re­venge, CEO Doug In­gram had this to say: “To those may be­lieve that the CRL sug­gest some sort of bias on be­half of the di­vi­sion of neu­rol­o­gy to­wards Sarep­ta, I would un­equiv­o­cal­ly and em­phat­i­cal­ly dis­agree. Let me re­it­er­ate that I re­main con­vinced that we were treat­ed very fair­ly and pro­fes­sion­al­ly by the di­vi­sion of neu­rol­o­gy.”

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