Sun Pharma gets CDSCO nod to market Tofacitinib to treat Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis

New Delhi: In a significant development, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted approval to pharma major Sun Pharmaceuticals to manufacture and market Tofacitinib ER Tablets 11mg for the treatment of Rheumatoid Arthritis, Psoriatic Arthritis, and Ulcerative Colitis.

This came after the drug maker Sun Pharma presented the proposal for manufacturing and marketing of Tofacitinib ER Tablets 11mg along with bioavailability (BE) Study report before the committee.

Tofacitinib is a partial and reversible janus kinase (JAK) inihibitor that will prevent the body from responding to cytokine signals. By inhibiting JAKs, tofacitinib prevents the phosphorylation and activation of STATs. The JAK-STAT signalling pathway is involved in the transcription of cells involved in hematopoiesis, and immune cell function. Tofacitinib works therapeutically by inhibiting the JAK-STAT pathway to decrease the inflammatory response.

At the recent SEC meeting for analgesic and rheumatology, the committee noted that Tofacitinib ER Tablets 11mg is indicated for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) who have an inadequate response or intolerance to one or more TNF blockers.

In addition, it is further noted that the drug is indicated for the treatment of adult patients with active psoriatic arthritis (PsA) who have an inadequate response or intolerance to one or more TNF blockers.

Furthermore, it is stated that the drug is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers.

The committee noted that the drug Tofacitinib ER Tablets 11mg is approved in US.

After detailed deliberation, the committee recommended for grant of permission to manufacture and market Tofacitinib ER Tablets 11mg for the following indication:-

1. Rheumatoid Arthritis: It is indicated for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) who have an inadequate response or intolerance to one or more TNF blockers.

2. Psoriatic Arthritis: It is indicated for the treatment of adult patients with active psoriatic arthritis (PsA) who have an inadequate response or intolerance to one or more TNF blockers.

3. Ulcerative Colitis: It is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have an inadequate response or intolerance to one or more TNF blockers.

Furthermore, the expert panel directed the firm that the firm should conduct the Active PMS study and accordingly, the firm should submit Active PMS Study protocol within 03 months after approval of the product.