CDSCO Panel Grants Novartis Protocol Amendment Proposal For Ianalumab
Written By : Dr. Divya Colin
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-04-27 12:30 GMT | Update On 2024-04-27 12:30 GMT
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New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novartis' protocol amendment proposal for the drug Ianalumab (VAY736).
This came after Novartis presented protocol amendment version 03 dated 27 Apr 2023 and protocol amendment 04 dated 14 Dec 2023, protocol No. CVAY736I12301. The above study is a phase III, randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to first-line corticosteroids in primary immune thrombocytopenia (VAYHIT1).
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