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