Bayer Pharma gets CDSCO Panel nod to study Asundexian 50mg tablets
New Delhi: Bayer Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase III clinical trial of Asundexian (BAY 2433334) tablets.
However, this approval is subject to the condition that clarity on PFO (patent foramen ovale) and arterial episode findings in Echo as embolic or nonembolic shall be mentioned in the inclusion criteria.
This came after Bayer Pharmaceutical presented the Phase III Clinical study protocol no. 20604.
Asundexian (BAY 2433334) is an orally active coagulation factor Xia (FXIa) inhibitor. Asundexian binds directly, potently, and reversibly to the active site of FXIa and thereby inhibits its activity.
Asundexian inhibited human FXIa with high potency and selectivity. It reduced FXIa activity, thrombin generation triggered by contact activation or low concentrations of tissue factor, and prolonged activated partial thromboplastin time in humans, rabbits, and various other species, but not in rodents.
At the recent SEC meeting for Neurology and Psychiatry held on 12th and 13th December 2023, the expert panel reviewed the Phase III clinical study protocol of the anticoagulant Asundexian presented by Bayer Pharmaceutical.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm with conditions that clarity on PFO and arterial episode findings in Echo as embolic or non-embolic shall be mentioned in the inclusion criteria.
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