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Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis

Pfizer Announces Start of Phase 3 Clinical Trial in Adults for Investigational Vaccine Against Respiratory Syncytial Virus

Pfizer Inc. announced the initiation of RENOIR, a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus bivalent prefusion F subunit investigational vaccine candidate in adults ages 60 years or older. The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. The primary objectives of the study will assess safety and efficacy for the prevention of moderate to severe lower respiratory tract illness (msLRTI-RSV) during the first RSV season. RSV is a seasonal illness that commonly starts in the fall months, peaking in the winter when colds and other respiratory illnesses are more common. Respiratory syncytial virus is a common and pervasive cause of acute respiratory illness. The virus is highly contagious and affects the lungs and airways. Infections occur in people of all ages and can feel like the common cold for most young adults, but for infants, the immunocompromised, and older adults, it can be potentially life-threatening. The risk of serious infection increases in older adults and for those with chronic heart or lung disease or a weakened immune system. In the U.S., it is estimated that more than 177,000 older adults =65 years of age are hospitalized and 14,000 of them die each year due to RSV. 2,6 There is no vaccine to prevent RSV and the medical community is limited to offering only supportive care for those with the illness.

Positive Top-Line Results From Pfizer’s Phase 3 JADE DARE Trial Comparing the Efficacy of Abrocitinib and Dupilumab for Moderate to Severe Atopic Dermatitis

Pfizer Inc. announced that JADE DARE (B7451050), a 26-week, randomized, double-blind, double-dummy, active-controlled, multi-center Phase 3 study, met its co-primary and key secondary efficacy endpoints. The study showed that abrocitinib was statistically superior compared to dupilumab in each evaluated efficacy measure and had a safety profile consistent with previous studies. The head-to-head study was designed to directly compare the efficacy of abrocitinib 200mg versus dupilumab 300mg, in adult participants on background topical therapy with moderate to severe atopic dermatitis (AD). Abrocitinib 200mg was administered by once-daily oral tablet and dupilumab was administered by subcutaneous injection every other week following a 600mg induction dose. The co-primary efficacy endpoints in JADE DARE were the proportion of patients achieving at least a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline at Week 2 and the proportion of patients achieving Eczema Area and Severity Index (EASI)-90 (=90% improvement from baseline) at Week 4. The key secondary endpoint was the proportion of patients achieving EASI-90 at Week 16. The study will allow assessment of any difference in efficacy that may persist at month 6 of treatment. A larger percentage of patients treated with abrocitinib 200mg experienced adverse events compared to dupilumab 300mg. The proportion of patients experiencing serious adverse events, severe adverse events, and adverse events leading to study discontinuation were similar in both treatment arms. Two deaths occurred in patients treated with abrocitinib 200mg, which were characterized by the investigator as unrelated to the study drug. One death was attributed to COVID-19 and the second was attributed to intracranial hemorrhage and cardiorespiratory arrest, and classified as a major adverse cardiovascular event (MACE). There were no cases of malignancies or venous thromboembolism (VTE) events confirmed through adjudication. The safety profile seen with abrocitinib was consistent with previous studies in the JADE program. The study is part of the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program for abrocitinib. Full results from JADE DARE will be submitted for presentation at a future scientific meeting and publication in a medical journal. Additionally, at the appropriate time, Pfizer intends to share these data with the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world reviewing submissions for abrocitinib. Abrocitinib is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of atopic dermatitis, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).