Pfizer wins Xeljanz label update; registers four new trials across RSV, eczema, sleep apnea

Pfizer's biggest development this week was an FDA labeling approval for its tofacitinib franchise, alongside four newly registered studies still in early stages.

• The FDA approved supplement 42 to Xeljanz (tofacitinib citrate) tablets, supplement 28 to Xeljanz XR extended-release tablets, and supplement 15 to Xeljanz oral solution, all labeling submissions with an approval letter dated September 21, 2026 and updated labels posted September 22, 2026.
• A Phase 3 study of the RSVpreF vaccine in adults 60 and older will evaluate safety, tolerability, and immunogenicity of a respiratory syncytial virus prevention F subunit vaccine in participants 60 years of age and older¹, with participants in China receiving either RSVpreF or placebo while all US participants receive RSVpreF¹. The study is not yet recruiting¹ and plans to enroll 600 participants (estimated)¹.
• Pfizer registered a Phase 3 trial of abrocitinib in children 2 to under 6 years old with moderate-to-severe atopic dermatitis, where participants who continue to meet eligibility criteria at baseline will be randomized 2:1 to abrocitinib oral suspension at 100 mg adult equivalent dose level once daily or matching placebo². The study is not yet recruiting², plans to enroll 90 participants (estimated)², with primary completion estimated for April 2029.
• A Phase 3 trial called "VESPER-OSA 1" will test once-monthly berobenatide, also known as MET-097i or PF-08653944³, in adults with obstructive sleep apnea and overweight or obesity who use PAP therapy, where participants will be assigned by chance to receive either berobenatide or placebo, given as an injection under the skin approximately once a month³. The study is not yet recruiting³ and plans to enroll 258 participants (estimated)³, with the primary outcome measuring change from baseline in Apnea-Hypopnea Index (AHI) at Week 52³.
• Pfizer also registered an observational study using US electronic health records linked to US healthcare claims data to describe baseline demographic and clinical characteristics of alopecia areata patients prescribed ritlecitinib, assess its real-world effectiveness based on dermatologist-recorded outcomes, and evaluate ritlecitinib treatment patterns and concomitant use of standard of care medications among patients aged 12 years and older⁴. The study is listed as active not recruiting⁴, with an estimated enrollment of 7,500 participants (estimated)⁴.