FDA hits Supernus with double whammy, handing biotech a CRL and RTF on same day
Supernus had a bad Monday.
Yesterday, the Maryland biotech announced that two different therapies had been shot back by the FDA. The agency rejected their application to approve SPN-812, an experimental ADHD medication for kids and adolescents. And they refused to even consider an application for SPN-830, a continuous treatment pump meant for Parkinson’s disease.
The rejection is a significant blow to Supernus, which invested in four clinical trials for the ADHD med. The FDA doesn’t disclose its reasoning for rejecting a drug, but the company said it had to do with CMC issues, rather than safety or efficacy concerns. An in-house lab that does analytic testing recently changed locations, they said, raising questions in the agency about quality control.
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