Novartis Ruxolitinib Gets CDSCO Panel Okay for Acute and Chronic Graft Versus Host Disease

This nod is subjected to condition that the firm should submit safety and efficacy data of ongoing Global study and Post Marketing data related to said indication within one year from the approval for evaluation by the committee for its continued marketing.

This came after the drug maker Novartis presented their proposal for additional indication of Ruxolitinib Tablets 5/10/15/20 mg with local clinical trial waiver before the committee.

Ruxolitinib belongs to a class of medications called kinase inhibitors. It is mainly indicated in the treatment of intermediate or high-risk myelofibrosis and resistant forms of polycythemia vera and graft-vs-host disease. Ruxolitinib is a Janus-associated kinase (JAK) inhibitor with potential antineoplastic and immunomodulating activities. Ruxolitinib specifically binds to and inhibits protein tyrosine kinases JAK 1 and 2. This leads to a reduction in inflammation and an inhibition of cellular proliferation.

Topical ruxolitinib is indicated for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients. It is also advised in patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Topical ruxolitinib is also used in the treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Ruxolitinib reduced splenomegaly and improved symptoms of myelofibrosis, in clinical trials. It is known to be associated with dose-dependent cytopenias, including thrombocytopenia, anemia, and neutropenia. It is the first topical Janus kinase inhibitor approved in the United States.

Chronic graft versus host disease (GVHD) is a disease complication that can occur after a stem cell or bone marrow transplant, in which the newly transplanted donor cells attack the transplant recipient's body. The major symptoms of this complication include skin rash, mouth sores, dry eyes, liver inflammation, development of scar tissue in the skin and joints, and damage to the lungs. This is likely the result of a complex immune-mediated interaction between the donor and recipient cells.

GVHD occurs when the donor's T cells (the graft) see the patient's healthy cells (the host) as foreign. Later, those cells attack and damage them. GVHD disease can be mild, moderate, or severe. In some cases, it can be life-threatening. A patient receiving an allogeneic stem cell transplant will receive some type of GVHD prevention if the patient's donor is an identical twin. This may include removing T cells from the donor graft and/or giving medications to suppress the T cells in the graft so that they do not attack the patient's cells.

At the recent SEC meeting for Oncology and Hematology held on 13.07.2022, the expert panel reviewed the proposal for the additional indication of Ruxolitinib Tablets 5/10/15/20 mg with a local clinical trial waiver.

After detailed deliberation, the committee recommended the grant of permission for the additional indication of Ruxolitinib stating,

However, the approval for the additional indication of Ruxolitinib tablets 5/10/15/20 mg subject to the following condition:

(1). The firm should submit safety and efficacy data of ongoing Global study and Post Marketing data related to said indication within one year from the approval for evaluation by the committee for its continued marketing.

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