Pfizer cues up vitiligo filing for Litfulo after phase 3 win

Pfizer's Litfulo has cleared two pivotal phase 3 trials in skin-lightening disorder vitiligo, allowing the company to start preparing for regulatory filings.

The once-daily, oral TEC/JAK3 inhibitor has shown efficacy in active and stable nonsegmental vitiligo (NSV) – the most common form of the disease – in which the most common form of vitiligo, accounting for about 90% of cases, where pale white patches appear symmetrically on both sides of the body and change unpredictably over time.

In the TRANQUILLO and TRANQUILLO 2 trials, both doses of Litfulo (ritlecitinib) under test – 50 mg and 100 mg – delivered improvements over placebo on the facial and total body Vitiligo Area Scoring Index (VASI) at 52 weeks. TRANQUILLO enrolled patients aged 12 and over, while TRANQUILLO 2 was conducted in adults only.

Litfulo is already FDA-approved to treat alopecia areata, a form of hair loss, but so far has not generated enough annual revenues to warrant an individual breakout in Pfizer's financial reporting.

It competes in the alopecia category with Eli Lilly's Olumiant (baricitinib) and Sun Pharma's Leqselvi (deuruxolitinib) – both JAK1/2 inhibitors – as well as AbbVie's JAK1-targeted Rinvoq (upadacitinib). And if approved for the vitiligo indication, Litfulo will go head-to-head with Incyte's JAK1/2 inhibitor Opzelura (ruxolitinib) in the US and Rinvoq in Europe, the latter having been approved in the EU for both alopecia and NSV earlier this week.

Michael Vincent, Pfizer's chief inflammation and immunology officer, said the drug has a unique mechanism of action and the new trial results "give us confidence that, if approved, Litfulo could become a new oral systemic treatment option for adults living with NSV, significantly improving and potentially maintaining facial and total body repigmentation."

Opzelura cleared for atopic dermatitis

Also this week, Incyte claimed an EU approval for Opzelura as treatment for adults with moderate atopic dermatitis for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate.

The European Commission approval was based on the phase 3b TRuE AD4 trial, which showed that Opzelura improved the clinical signs and symptoms of moderate AD, including itch, as early as two days after starting treatment.

The product is the first steroid-free topical JAK inhibitor approved in the EU for atopic dermatitis, and has also been cleared for the disease in patients aged two and over in the US.

Photo by Hanen BOUBAHRI on Unsplash