Novo Nordisk gets CDSCO Panel nod to study NN0365-3769
New Delhi: In a significant development, the drug major Novo-Nordisk has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the study of the NN0365-3769 (Mim8) which aids in preventing bleeding in people with haemophilia A.
However, this approval is subject with a condition that the firm should submit interim efficacy and safety data of the first part of the study. The committee also stated that the trial should be resume once the expert panel reviews the data.
This came after the drug major Novo-Nordisk presented Phase IIIa clinical trial no NN7769-4516-FRONTIER 3 before the committee.
NN0365-3769 (Mim8) is a study of medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly). Mim8 is a new medication that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII). Mim8 will be injected with a thin needle in the skin of the stomach, using a pen-injector.
At the recent SEC meeting for Oncology & Haematology held on December 9th 2022, the expert panel reviewed the proposal presented by the drug major Novo-Nordisk for conducting the Phase IIIa clinical trial of the NN0365-3769 (Mim8) which aids in preventing bleeding in people with haemophilia A.
After detailed deliberation, the committee recommended the grant of permission to conduct the study with condition that the applicant should submit interim efficacy and safety data of first part of the study for further review by the committee and once data would be reviewed by the committee, trial might be continued.
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