Sanofi Healthcare Gets CDSCO Panel Nod to Import and Market Belumosudil Tablets

New Delhi: Noting an unmet medical need, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Sanofi Healthcare to import and market Belumosudil tablets 200 mg, with a condition to conduct a Phase IV clinical trial (CT) study involving high-volume transplant centers (more than 100) across the country.

This came after Sanofi Healthcare presented the published literature on the post-marketing safety data of Belumosudil tablets 200 mg from other countries, along with the Phase IV CT protocol, before the committee.

In regard to the above proposal, the expert panel noted that the proposed drug is an orphan drug approved in other countries and falls under unmet medical need. An orphan drug is a pharmaceutical agent that is developed to treat certain rare medical conditions.

Belumosudil is an oral inhibitor of rho-associated coiled-coil-containing protein kinases (ROCK) used in the treatment of chronic graft-versus-host disease (GVHD).

Chronic graft-versus-host disease (GVHD) is a life-threatening complication of allogeneic hematopoietic stem cell transplantation in which the transplanted donor T-cells recognize the recipient's tissues as foreign and mount an immune response.

Belumosudil is an inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a protein that plays a vital role in the pathogenesis of immune and fibrotic diseases. The inhibition of ROCK2 has been shown to resolve immune dysregulation by down-regulating pro-inflammatory Th17 cells and up-regulating regulatory T-cells by manipulating the phosphorylation of STAT3 and STAT5.

Belumosudil was first approved by the FDA in July 2021, under the brand name Rezurock, for the treatment of chronic GVHD in patients who have tried and failed at least two prior lines of systemic therapy. In July 2022, Belumosudil was approved by Health Canada under the brand name RHOLISTIQ to treat the same condition in adult and pediatric patients 12 years of age or older.

At the recent SEC meeting for Hematology held on June 18, 2023, the expert panel reviewed the published literature on post marketing safety data of Belumosudil tablets 200 mg, of other countries along with Phase IV CT protocol.

Noting that the proposed drug is an orphan drug approved in other countries and that it falls under unmet medical need, the committee agreed to the Phase III CT waiver.

After detailed deliberation, the committee recommended the grant of permission to import and market Belumosudil tablets 200 mg, with a condition to conduct a Phase IV CT study involving high-volume transplant centers (more than 100) across the country.

Accordingly, the expert panel suggested that the firm submit a Phase IV study protocol within 3 months from the date of approval to CDSCO for further evaluation by the committee.

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