Novo Nordisk Gets CDSCO Panel Nod to study recombinant coagulation factor XIII, Novothirteen

Published On 2023-05-08 12:30 GMT | Update On 2023-05-08 12:30 GMT

New Delhi: Pharmaceutical major, Novo Nordisk has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) for the conduct of a post-marketing surveillance (PMS) study titled “post-marketing surveillance program of catridecacog (Novothirteen) use in congenital FXIII A-subunit deficiency patients of India.”However, the...

However, the nod is subject to the condition that the firm should submit the safety data generated globally and include more centers/sites to get an adequate number of patients for the proposed PMS study.

This came after the firm presented the protocol for the conduct of post-marketing surveillance in a study titled “Post-marketing surveillance program of catridecacog (Novothirteen) use in congenital FXIII A-subunit deficiency patients of India” as per Protocol No. NN1841-7592, version 1.0 dated 24 Nov. 2022.

The active ingredient in NovoThirteen is recombinant coagulation factor XIII (rFXIII), which is also called catridecacog (rys). NovoThirteen is made by genetic engineering.

Novothirteen contains the active substance catridecacog which is used to prevent bleeding in patients. Catridecacog is a recombinant FXIII subunit‐A molecule evaluated for clotting factor replacement therapy in congenital FXIII deficiency.

NovoThirteen is a medicine that prevents excessive bleeding in patients with an inherited blood clotting disorder called ‘congenital factor XIII A-subunit deficiency’. It is used to prevent bleeding and treat any episodes of bleeding that occur during preventative treatment.

At the recent SEC meeting for Oncology and Hematology held on 27th April 2023, the expert panel reviewed the protocol presented by the drug major Novo Nordisk to conduct the post-marketing surveillance study titled “post-marketing surveillance program of catridecacog (Novothirteen) use in congenital FXIII A-subunit deficiency patients of India”.

After detailed deliberation, the committee recommended the grant of permission to conduct the post-marketing surveillance study as per the presented protocol subject to the following conditions-

1. The firm should submit safety data generated globally so far to CDSCO.

2. The firm should include more centers/sites to get an adequate number of patients for the proposed PMS study

Also Read:Emcure Pharmaceuticals Gets CDSCO To Manufacture & Market the FDC Antiviral Drug

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Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

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Novo Nordisk Gets CDSCO Panel Nod to study recombinant coagulation factor XIII, Novothirteen

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