Conduct phase 3 trial of plaque psoriasis FDC drug on Indian patients: CDSCO panel tells Glenmark

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Organization (CDSCO) has recommended Glenmark Pharmaceuticals to conduct a Phase III clinical trial of the proposed Fixed Dose Combination (FDC) of Calcipotriene 0.005% plus Betamethasone dipropionate 0.064% topical suspension in Indian patients.

This recommendation came in the wake of the proposal presented by Glenmark Pharmaceuticals before the committee along with Phase III data generated in the US.

Calcipotriene 0.005 percent–betamethasone dipropionate 0.064 percent topical suspension (C/Bd-TS) applied once daily is effective, well tolerated, and safe for treating plaque psoriasis (PP) involving the scalp and/or other body sites such as the trunk and extremities.

Psoriasis is the most common immune-mediated inflammatory disease, affecting the skin and joints and often accompanied by systemic abnormalities. The most prevalent kind of psoriasis is plaque psoriasis. In plaque psoriasis, large oval-circular plaques appear on the scalp, trunk, and extensor body areas.

Calcipotriene 0.005 percent–betamethasone dipropionate 0.064 percent topical suspension (C/Bd-TS) is an effective treatment for PP in patients with localised disease, as well as those who have been treated systemically or with phototherapy for more extensive disease and have persistent or recurrent PP.

Calcipotriene is a synthetic analog of vitamin D, used in combination with betamethasone dipropionate for the topical treatment of plaque psoriasis in adult patients. Betamethasone is a long-acting corticosteroid with immunosuppressive and antiinflammatory properties.

This combination is available in a variety of forms, including ointment, gel, spray, and foam. The ointment was authorised by the FDA in 2004 and is indicated for the once-daily topical treatment of plaque-type psoriasis vulgaris amenable to topical therapy. The FDA authorised the foam formulation in 2015, and it is intended for the topical treatment of plaque psoriasis in individuals aged twelve and above.

At the 60th SEC meeting for Dermatology & Allergy held on 12.08.2021, the committee thoroughly examined the proposal presented by Glenmark Pharmaceuticals.

Following a thorough examination, the committee noted that the firm had not conducted Phase III clinical trials in India.

After detailed deliberation, the committee recommended that the firm should conduct a Phase III clinical trial in Indian patients and, accordingly, the Phase III CT protocol should be submitted for further review by the committee.