{"id":49025,"date":"2025-11-26T13:48:37","date_gmt":"2025-11-26T05:48:37","guid":{"rendered":"https:\/\/flcube.com\/?p=49025"},"modified":"2025-11-26T13:48:38","modified_gmt":"2025-11-26T05:48:38","slug":"novartiss-itvisma-wins-fda-approval-as-first-gene-therapy-for-sma","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=49025","title":{"rendered":"Novartis’s Itvisma Wins FDA Approval as First Gene Therapy for SMA"},"content":{"rendered":"\n

Novartis AG<\/strong> (NYSE: NVS<\/a>) announced that Itvisma (onasemnogene abeparvovec\u2011brve)<\/strong> received U.S. FDA approval<\/strong> for children aged two and older, teens, and adults with Spinal Muscular Atrophy (SMA)<\/strong> caused by SMN1 gene mutations, becoming the first and only gene replacement therapy<\/strong> for this broad population.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Item<\/th>Detail<\/th><\/tr><\/thead>
Product<\/strong><\/td>Itvisma (onasemnogene abeparvovec\u2011brve)<\/td><\/tr>
Company<\/strong><\/td>Novartis AG (NYSE: NVS)<\/td><\/tr>
Agency<\/strong><\/td>U.S. Food and Drug Administration (FDA)<\/td><\/tr>
Approval Date<\/strong><\/td>24\u202fNov\u202f2025<\/td><\/tr>
Indication<\/strong><\/td>SMA in patients aged \u22652 years with confirmed SMN1 mutation<\/td><\/tr>
Significance<\/strong><\/td>First gene replacement therapy for this population<\/td><\/tr>
Administration<\/strong><\/td>Single one-time intrathecal injection<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Drug Profile<\/h2>\n\n\n\n