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Pfizer wins FDA approval for its $7B colitis drug

Dive Brief:

  • The Food and Drug Administration on Friday approved Pfizer’s Velsipity to treat ulcerative colitis, making it the second pill of its type cleared for use in inflammatory bowel disease, the company said. Velsipity enters a market with several oral and injectable drugs which block the immune response that causes the disease, including one in its class, Bristol Myers Squibb’s Zeposia.

  • Pfizer acquired the medicine through its $6.7 billion buyout of Arena Pharmaceuticals in 2021. The big drugmaker hopes Velisipity, which slows the entry of white blood cells into the bloodstream, can also work in other immune-related conditions like Crohn’s disease, alopecia areata and eczema.

  • Pfizer expects to add $25 billion in revenue by 2030 from new products acquired through biotech buyouts and licensings. The additional revenue will help cushion the company against revenue declines from its COVID-19 products as well as loss of patent protection for older drugs.

Dive Insight:

In clinical trials, Velsipity helped 27% of patients taking it go into remission at 12 weeks and 32% at 52 weeks, significantly higher than the 7% of patients who received placebos at both time points. The pill also showed a benefit on other endpoints Pfizer studied, such as improvement based on measurements taken through an endoscope.

Pfizer set a list price of $6,164 for a 30-day supply of the once-daily pill, or about $75,000 a year. That is in line with oral treatments like Pfizer’s own Xeljanz and AbbVie’s Rinvoq, and less than the $100,000 annual price Bristol Myers set for Zeposia.

Zeposia was first approved as a multiple sclerosis drug, allowing it to command a higher price but one that is “not suitable” for digestive diseases like ulcerative colitis, Evercore ISI analyst Umer Raffat wrote in a note to clients.

Velsipity and Zeposia are a type of drug called S1P receptor modulators, while Xeljanz and Rinvoq work differently, inhibiting enzymes known as JAKs. The latter class has been dogged by warnings about complications for blood clots, potentially making the S1P drugs an attractive alternative.

Other treatments are biologic drugs that require frequent injections. The least costly new drug for ulcerative colitis is Takeda’s Entyvio, priced at about $50,000 a year, although others are priced at significantly more than $100,000 a year.

“Because of the unpredictable nature of UC, people living with the disease can cycle through several different treatments over time,” said Michael Chiorean, co-director of the IBD Center at Swedish Medical Center and an investigator in Pfizer’s clinical trials, in a statement. “Patients may also be apprehensive about using injectable therapies, like biologics.”