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FDA Approves Oral Tx for UC – Velsipity

…………..catching up on recent FDA approvals

The FDA recently approved a new ORAL therapy, Velsipity (etrasimod) from Pfizer, for adults with moderately to severely active ulcerative colitis (UC).  Velsipity is a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P receptor subtypes 1, 4, and 5.

UC is a chronic, debilitating condition affecting about 1.25 million people in the United States. Symptoms often include chronic diarrhea with blood and mucus, abdominal pain, and urgency.  The therapy provides patients the opportunity to achieve steroid-free remission.

Velsipity has launched with a wholesale acquisition cost is $6,164 for 30-day supply or ~$75,000 annually. Pfizer did not disclose distribution details although, given its cost, it is highly likely to be dispensed only through specialty pharmacy limited distribution.

CLICK HERE to read prescribing information

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U.S. FDA Approves Pfizer’s Velsipity for Adults with Moderately to Severely Active Ulcerative Colitis

CLICK HERE to read the full press release

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Limited Distribution Updates

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the early press releases

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