Last Updated on December 22, 2024 by The Health Master
USFDA approval
In a significant development, the U.S. Food and Drug Administration (USFDA) has granted USFDA approval for Pfizer’s groundbreaking drug, Velsipity, designed to alleviate symptoms of the inflammatory bowel disease known as ulcerative colitis.
This milestone is a testament to the promising results yielded from a comprehensive late-stage study, showcasing notable improvements in patients who received the drug as opposed to a placebo.
The Breakthrough: Velsipity and its Significance
1. Background of Velsipity:
Velsipity, chemically identified as etrasimod, emerged as the linchpin of Pfizer’s strategic acquisition of Arena Pharmaceuticals, a deal valued at a staggering $6.7 billion, consummated just last year.
2. Mechanism of Action:
Falling within a category of drugs aimed at modulating the body’s immune response, Velsipity is poised to be a formidable contender against Bristol Myers Squibb’s Zeposia, which gained USFDA approval in 2021.
3. Market Potential:
The global landscape for inflammatory bowel diseases commands a substantial market size, estimated at approximately $20 billion. This underscores the immense economic potential that drug manufacturers perceive in this therapeutic domain.
4. Anticipated Sales and Impact:
Analysts, in their projections last year, speculated that Velsipity could potentially achieve peak sales exceeding $3 billion annually, further highlighting the immense promise and market confidence surrounding this drug.
Understanding Ulcerative Colitis
1. Nature of Ulcerative Colitis:
Ulcerative colitis is a debilitating condition characterized by the development of ulcers within the digestive tract. It manifests with distressing symptoms including abdominal pain, rectal bleeding, and incontinence, significantly impeding the quality of life for those affected.
2. Prevalence in the U.S.:
According to Pfizer, approximately 1.25 million individuals in the United States grapple with this condition, underscoring the pressing need for innovative and effective treatments.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
USFDA Approved Weight Loss Drugs: A Comprehensive Guide
USFDA approval granted Esomeprazole Magnesium DR Capsules
USFDA approval granted for Tolvaptan tablets
USFDA approval granted for Icosapent Ethyl Capsules
USFDA Approval granted for this Generic Hypertension Medication
USFDA issues Form 483 with 9 observation to Dr Reddy’s laboratories: Hyderabad
Regulatory Changes: Relief for Class C and D Medical Device in India
Govt Job: Unlocking Opportunities for CDSCO Recruitment 2023
USFDA issued EIR to InvaGen Pharma of Cipla
Understanding the New Price Regulations for Orthopaedic Knee Implants: NPPA
Drug recall: These injections recalled due to Glass Particulate Matter
IPC: Indian Pharmacopoeia Commission joins the Pharmacopoeial Discussion Group
USFDA issues Form 483 with one observation to Aurobindo Unit IV: Andhra Pradesh
Pakistan: New technology introduced for instant detection of spurious drugs
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: