Novartis Gets CDSCO Panel Nod to Study XXB750 in Patients With Heart Failure
New Delhi: The drug major Novartis has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the Phase II clinical study of XXB750 in patients with heart failure.
This came after Novartis presented Phase II clinical study protocol No. CXXB750A12201. This is a multicenter, randomized, placebo- and active-controlled, parallel-group, 24-week trial to investigate the efficacy, safety, and tolerability of XXB750 in participants with HFrEF/HFmrEF.
Eligible participants will be randomized to receive either subcutaneous (s.c.) XXB750 or placebo; or sacubitril/valsartan for 16 weeks, and then followed-up for 8 weeks
However, this approval is subject to the condition that approximately 50% of sites and subjects should be enrolled from Govt. sites. Furthermore, the expert panel suggested that private study sites of university medical colleges only be included in the study.
XXB 750 is an experimental injected drug that targets natriuretic peptide (NPR1) and is developed to treat resistant hypertension. It was also tried for heart failure with reduced ejection fraction.
At the recent SEC meeting for Cardiovascular held on 9th January 2023, the expert panel reviewed the protocol presented by the drug major Novartis for the Phase II clinical trial of XXB750.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial subject to the condition that
(1) Approximately 50% of sites and subjects shall be enrolled from Govt. sites.
(2) Private study sites of university medical colleges only shall be included in the study.
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