Novo Nordisk Eptacog alfa gets CDSCO panel nod for Additional Indication

However, the approval is subjected to the condition that the firm conduct a Phase IV study for the proposed indication.

This came after the drug major Novo Nordisk proposed a new indication for Eptacog Alfa, indicating "for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis."

Postpartum hemorrhage (also called PPH) is when a woman has heavy bleeding after giving birth. It's a serious but rare condition. It usually happens within 1 day of giving birth, but it can happen up to 12 weeks after having a baby.

Eptacog alfa is a recombinant factor VIIa product developed by Novo Nordisk. In India, Eptacog alfa is approved under the brand name NovoSeven. NovoSeven is a vitamin K-dependent glycoprotein consisting of 406 amino acid residues (MW of 50 K Dalton). NovoSeven is structurally similar to human plasma-derived Factor VIIa.

Eptacog alfa is used in the treatment and prevention of bleeding. It helps prevent excessive bleeding after surgery or other important treatments, specifically in patients with haemophilia or those with other bleeding disorders. Eptacog alfa is a blood clotting factor. It works by facilitating the formation of blood clots at the site of bleeding when the body's own clotting factors are not working.

At the recent SEC meeting for Oncology & Haematology held on 07.10.2022, the expert panel reviewed the drug major Novo Nordisk's proposal for approval of an additional indication of Recombinant Factor VIIa, Eptacog Alfa, indicating "for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis".

The committee noted that the proposed indication is approved by the European Medicines Agency (EMA).

After detailed deliberation, the committee recommended the grant of approval of Eptacogalfa (activated) 1 mg/vial and 2 mg/vial for the proposed indication in line with EMA approval with the condition that the firm should conduct a Phase IV study for the proposed indication.

In addition, the expert panel directed the firm to submit a Phase IV study protocol to CDSCO within three months of approval of the additional indication.