Sarepta's Shadow: BioMarin Mulls Turning The Extraordinary Into A Template
Circumstances of FDA's approval of Sarepta's Exondys 51 approval may give BioMarin reason to appeal the complete response for its Duchenne muscular dystrophy treatment drisapersen – but its high-quality data could preclude success.
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A legal settlement with BioMarin means that Sarepta doesn't have to worry anymore about the potential to infringe patents related to exon-skipping DMD therapies. Meanwhile, BioMarin gains some compensation for its ill-fated Prosensa buy.
Exondys 51 has been met with recommendations for restrictions by many insurers, but after consultations with experts and Sarepta execs coverage is expanding.
EMA and payers want to know more about daily life improvements from US FDA-approved Duchenne muscular dystrophy treatment.