Dainippon Sumitomo - R&D Day Turns ‘Latuda Day’ – Signals Timely sNDA Filing For Bio-Polar Disorder!
Dainippon Sumitomo Pharma (DSP) has help R&D day recently and kew take away was that Latuda (lurasidone) development plans remain on track and sNDA filing for bi-polar disorder is expected to take place per schedule in 3Q 12. DSP provides some detailed data on PREVAIL 1 and PREVAIL 2 study on bi-polar disorder that met its primary and secondary endpoints and demonstrated a safety profile that was consistent with previous PEARL trials (schizophrenia), and continues to show its good metabolic side-effect profile – one of the key feature, giving an edge to Latuda over existing therapies to some extent. If approved, this will be first drug in combination with mood stabilizing drugs (i.e. lithium or valporate) for bi-polar I depression.
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Dainippon Sumitomo
Dainippon Sumitomo
