Pfizer currently undergoing regulatory review for the treatment of atopic dermatitis Early data Shows that it defeated Regeneron Pharmaceutical’s best seller Dupixent in a face-to-face study. But the fate of Pfizer’s abrocitinib is still uncertain, as the FDA continues to review safety data that may have an impact on the entire drug category.
Atopic dermatitis, commonly called eczema, is an autoimmune disease that causes redness and itching of the skin. Pfizer’s drug is an oral tablet once a day, while Regeneron’s drug is injected subcutaneously every other week. Pfizer’s drug was tested in a phase 3 clinical trial that recruited approximately 600 volunteers. In preliminary data from the 26-week study released on Monday, Pfizer stated that abrocitinib beat Dupixent on two main goals, evaluating the two drugs on a scale that measures the severity of eczema.
Although oral preparations and clinical data show that abrocitinib’s superior efficacy indicates that it may have a competitive advantage with Dupixent, safety may be a stumbling block. Abrocitinib is a small molecule that blocks Janus kinase (JAK) 1, an enzyme that is thought to regulate cell signaling proteins involved in the development of atopic dermatitis. Currently approved JAK inhibitors carry the strictest FDA safety risk warning on their label. Rheumatoid arthritis (RA) is the first target of JAK inhibitors, and three of them have passed the regulatory standards for RA, including Pfizer’s tofacitinib, which was approved for the treatment of the disease in 2012. And it went on sale under the name “Xeljanz”.
The FDA is expected to make a decision on abrocitinib in the second quarter of this year, but in April Pfizer announced that the agency’s review was Expand Three months to the third quarter.In an update announced last month, Pfizer stated that the FDA has notify The company said it will not be able to meet the regulatory decision on abrocitinib in RA and Xeljanz’s revised target date for extending the approval of the drug to ankylosing spondylitis, inflammatory arthritis that affects the spine. According to Pfizer, one factor cited by the FDA is Xeljanz’s ongoing post-market safety review in the RA.The review was conducted after a report in January Results after listing In RA, Xeljanz is no better than the old class of drugs based on the assessment of the association with cardiovascular problems and cancer.
Pfizer said at the time that it had not yet obtained the complete data of the post-marketing study, and it was cooperating with the FDA to review the results and analysis. Abrocitinib is not the only drug whose fate depends on FDA review. AbbVie and Eli Lilly’s JAK inhibitor regulatory decisions are also in a state of uncertainty.
Dupixent, jointly sold by Regeneron and Sanofi, had sales of more than 4 billion U.S. dollars last year. In addition to atopic dermatitis, the drug is also approved for the treatment of asthma and chronic sinusitis. In the results of the abrocitinib/Dupixent head-to-head study reported on Monday, Pfizer stated that patients receiving Dupixent had a greater proportion of adverse events than patients receiving Dupixent. The company did not specify how many patients experienced adverse events or the nature of these problems. But it said that the proportion of patients with adverse events in the two treatment groups was similar.
Two deaths occurred in the abrocitinib-administered group, one was attributed to Covid-19, and the other was classified as a major adverse cardiovascular event. Pfizer said that clinical trial researchers believe that these deaths have nothing to do with the study drug.
No cancer cases of venous thromboembolism were reported in the study. Pfizer added that the safety of abutinib is consistent with earlier studies. In a phase 3 study of 838 patients, the study tested two doses of abroxitinib against Dupixent and placebo. The results showed that among high-dose abroxitinib, 11.1% of patients reported Nausea; 4.2% of patients were in the low-dose group. Acne occurred in 6.6% of the high-dose group and 2.9% of the low-dose group.turn out Publish Published in the New England Journal of Medicine in March.
Pfizer said that the complete results of the latest abrocitinib study will be submitted to future scientific conferences and published in medical journals. The company added that it plans to share data with the FDA and other regulatory agencies “in due course.”
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