Pfizer announced on Friday that the Food and Drug Administration (FDA) has granted approval for its latest ulcerative colitis medication, etrasimod, to be marketed under the name Velsipity.
Expanding Product Portfolio
This approval marks one of several new product launches for Pfizer in the second half of the year. Among these launches is a respiratory syncytial virus vaccine specifically designed for expectant mothers. Despite these recent developments, Pfizer (PFE) shares have experienced a 36% decline in 2023 due to uncertainties surrounding the long-term value of the company’s Covid-19 vaccine franchise.
Treatment for Moderately to Severely Active Ulcerative Colitis
Velsipity has been approved by the FDA to effectively treat “moderately to severely active ulcerative colitis in adults.” Ulcerative colitis is a chronic condition known to cause persistent symptoms such as chronic diarrhea.
Promising Clinical Trials Results
In a Phase 3 trial, Velsipity demonstrated significant efficacy with 32% of patients experiencing clinical remission after a year of treatment. This percentage far surpasses the mere 7% of patients who achieved remission while receiving a placebo.
Projected Revenue and Growth Prospects
Last year, Pfizer projected that their global revenue from Velsipity, specifically for the treatment of ulcerative colitis, would reach a peak between $1 billion and $2 billion. This innovative medication is part of an array of new products that Pfizer anticipates will generate a combined potential annual revenue of $20 billion by 2030.
Key Benefits of Velsipity
Pfizer’s Chief Commercial Officer, Angela Hwang, emphasized the advantages of Velsipity, stating that it provides adults living with moderately to severely active ulcerative colitis the opportunity to achieve steroid-free remission. The drug is administered once-daily in the form of an oral pill, offering a favorable benefit-risk profile.
Acquiring Velsipity
Pfizer gained ownership of Velsipity through its acquisition of Arena Pharmaceuticals in 2022, a deal totaling $6.7 billion. Velsipity falls under the category of drugs known as sphingosine 1-phosphate receptor modulators. These types of medications are also utilized in the treatment of multiple sclerosis. In 2021, Bristol Myers Squibb’s (BMY) sphingosine 1-phosphate receptor Zeposia also gained FDA approval as a treatment for ulcerative colitis.
