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Find Clinical Drug Pipeline Developments & Deals for MolPort-001-758-008
Under the terms of the agreement, Chiesi Group acquired all assets and certain liabilities related to Raxone (idebenone) in all indications worldwide, including Raxone in leber hereditary optic neuropathy (LHON).
Data from an interim analysis conducted by the independent Data and Safety Monitoring Board concluded that the Phase 3 SIDEROS study with Puldysa® (idebenone) was unlikely to meet its primary endpoint.
Data from an interim analysis conducted by the (DSMB) concluded that the study was unlikely to meet its primary endpoint. Santhera will discontinue the study, withdraw the European marketing authorization application and end the global development program for Puldysa.
Uk's Medicines and Healthcare products Regulatory Agency has renewed for a further year the Early Access to Medicines Scheme scientific opinion for idebenone for patients with Duchenne muscular dystrophy in respiratory function decline who are not taking glucocorticoids.
In combination with Santhera's existing cash and cash equivalents, this financing will provide the Company with sufficient funding to complete regulatory work for Puldysa®, including the CHMP review, and with the achievement of Company milestones.
The large Phase 3 SIDEROS study was designed to confirm the efficacy of idebenone in patients with respiratory function decline who are concurrently taking glucocorticoids.