Submit Phase III CT data with Pk and Pd data: CDSCO Panel Tells Intas Pharmaceuticals on Human von Willebrand Factor

New Delhi: In response to the proposal for the grant of permission to manufacture Human von Willebrand Factor EP 600 IU (Freeze Dried Powder) Drug Formulation, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended that Intas Pharmaceutical submit the Phase III clinical trial data with pharmacokinetics (Pk) and pharmacodynamic (Pd) data of the proposed drug.

In addition, the committee recommended that the firm may submit the protocol of the study for consideration.

This came after the firm presented the proposal for a grant of permission to manufacture the Human von Willebrand Factor EP 600 IU (Freeze Dried Powder) drug formulation with a local clinical trial (CT) Phase-III waiver.

Von Willebrand factor is a human blood clotting factor used to manage bleeding episodes in von Willebrand disease and hemophilia A.

The von Willebrand factor (vWF) is indicated to manage and control bleeding episodes in adults with von Willebrand disease. It is also used for perioperative management of bleeding in these patients. It is also used for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand disease receiving on-demand therapy.

At the recent SEC meeting for Hematology, the expert panel reviewed the proposal for the grant of permission to manufacture Human von Willebrand Factor EP 600 IU (Freeze Dried Powder) Drug Formulation with local CT Phase-III waiver.

After detailed deliberation, the committee recommended that the firm should submit Phase-III CT data along with Pk and Pd data.

Accordingly, the expert panel suggested that the firm may submit the protocol, etc. for the consideration of the committee.

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