Biogen Inc BIIB said its newly approved Spinraza (nusinersen) would be available in just one week time. Spinraza is approved to treat spinal muscular atrophy, a form of muscle weakness.
The company, which got the FDA approval within three months of regulatory filing, said Spinraza will be made available for shipment in the United States to healthcare providers in approximately one week. The drug was approved based on positive results from multiple clinical studies in more than 170 patients.
Biogen licensed the global rights to develop, manufacture and commercialize Spinraza from Ionis Pharmaceuticals Inc IONS.
Recent Drug Approvals Through Accelerated Pathway
Following are the recent drugs that have been approved by accelerated pathway:
- This month, the U.S. Food and Drug Administration granted accelerated approval to Clovis Oncology Inc CLVS's Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. At that time, Clovis said Rubraca will be available in the United States immediately.
- In October, Eli Lilly and Co LLY received accelerated for olaratumab (Lartruvo) to treat adults with advanced soft tissue sarcomas.
- In September, Sarepta Therapeutics Inc SRPT announced the U.S. Food and Drug Administration has granted accelerated approval for EXONDYS 51 (eteplirsen) for the treatment of Duchenne muscular dystrophy.
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