The Subject expert committee, SEC of CDSCO recommended grant of permission for manufacturing and marketing and permission to conduct the Phase IV Clinical trial of Sovateltide injection by Pharmazz India.
Pharmazz India has submitted an application to receive permission for manufacturing, marketing and conduct phase IV trial in the country. Earlier SEC meeting held on 28.06.2022, the firm presented a proposal for permission for manufacturing and marketing along with Phase IV Clinical trial protocol before the committee.
After detailed deliberation, the committee recommended grant of permission for manufacturing and marketing and permission to conduct the Phase IV Clinical trial as per the presented protocol subject to few conditions.
The SEC asks Pharmazz India to follow conditions, as it should initiate the clinical trial within three months of launching the product in the market. Revised package insert should be submitted to CDSCO for review; Approval of Revised Package Insert, Label and Carton to be adopted should be obtained from CDSCO before launching the product marketing. And the drug should be available on prescription from a specialist only.
Three geographically distributed clinical trial sites should be inspected to verify GCP compliance before grant of manufacturing and marketing permission.
Sovateltide is an endothelin B receptor agonist that increases blood flow, shows anti-apoptotic activity, produces neurovascular remodeling, and protects neural mitochondria.
In May 2022, Pharmazz Inc. announced positive results of phase III Clinical Trial evaluating sovateltide as a treatment for Acute Cerebral Ischemic Stroke.
