CDSCO Panel approves Roche's PMS Study Report of Rituximab with Glucocorticoids in Wegener's Granulomatosis

This came after the drug major Roche presented the report (CSR Version 1.0 dated April 2023) of the conducting PMS study titled “An Open Label, Prospective, Post Marketing Study to Evaluate the Safety, tolerability, and Efficacy of Rituximab with Glucocorticoids in Adult Patients with Wegener’s Granulomatosis(Granulomatosis With Polyangiitis-GPA) Or microscopic polyangiitis” vide Protocol No. ML28550.

Granulomatosis with polyangiitis is an uncommon disorder that causes inflammation of the blood vessels in the nose, sinuses, throat, lungs, and kidneys. Formerly called Wegener's granulomatosis, this condition is one of a group of blood vessel disorders called vasculitis. It slows blood flow to some of the organs.

Rituximab injection products are in a class of medications called monoclonal antibodies. Rituximab is a monoclonal anti-CD20 antibody used to treat non-Hodgkin's lymphoma, chronic lymphocytic leukemia, Wegener's granulomatosis, pemphigus vulgaris, and rheumatoid arthritis.

By targeting CD20, rituximab promotes cell lysis while sparing hematopoietic and plasma cells without this surface antigen. It has been suggested that cell lysis mechanisms triggered by rituximab include complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC).

At the recent SEC meeting for analgesic and rheumatology held on 8th and 9th November 2023, the expert panel reviewed the PMS study report of Rituximab with Glucocorticoids in adult patients with Wegener’s Granulomatosis(Granulomatosis With Polyangiitis-GPA) Or microscopic polyangiitis presented by drug major Roche.

After detailed deliberation, the committee noted and agreed with the results of the presented study.

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