Tofatas Ointment (tofacitinib ointment) / Intas - LARVOL DELTA

Topical Tofacitinib for Atopic Dermatitis - Outcomes from Randomized Phase 3 Clinical Trial: First Approval. (PubMed, Indian J Dermatol) - "These comprise topical Ruxolitinib, oral Abrocitinib, and Upadacitinib...The present trial was conducted to evaluate the efficacy and safety of tofacitinib ointment 2% w/w (Tof-O) versus pimecrolimus cream 1% w/w (Pim-C) in adult patients with mild-to-moderate AD...https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=71771&EncHid=&userName=tofacitinib%20ointment. Interventional."

Journal • P3 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pruritus

Intas Pharma Gets Expert Panel Nod For PMS Data On Tofacitinib Ointment In Atopic Dermatitis (Medical Dialogues) - "Intas Pharma has received approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) for the results of its Post-Marketing Surveillance (PMS) study on Tofacitinib 2% w/w ointment in adult patients with mild to moderate atopic dermatitis, including those experiencing flare-ups....The PMS study focused on adult patients diagnosed with mild to moderate atopic dermatitis, particularly those suffering from flare-ups of the condition. The firm submitted its findings before the committee for evaluation, which included real-world data collected under post-marketing conditions. After a comprehensive review and detailed deliberation, the committee acknowledged the results submitted by the company and recommended acceptance of the data presented in the PMS study."

Approval • Atopic Dermatitis

Intas launches Tofacitinib Ointment for Atopic Dermatitis patients (The Hindu Business Line) - "Intas Pharmaceuticals Ltd on Thursday announced the launch of TOFATAS - a tofacitinib ointment 2 per cent% w/w for the treatment of mild to moderate Atopic Dermatitis (AD) in patients 18 years and above having flare-ups of the disease. The ointment is approved by the regulator - Drug Controller General of India (DCGI)."

Launch non-US • Atopic Dermatitis • Immunology