Pfizer’s blockbuster drug Xeljanz snags FDA approval for ulcerative colitis

Pfizer’s (PFE) blockbuster drug Xeljanz has won itself a new regulatory approval to treat adults with inflammatory bowel disease (IBD). This recent approval will help propel the company’s sales significantly. Pfizer’s Xeljanz is the first and only JAK inhibitor that obtained the FDA’s blessing to treat intestinal diseases.

Xeljanz, the oral drug, is already experiencing blockbuster sales. The first approval came in 2012 to alleviate symptoms of rheumatoid arthritis. Next in 2017 to treat another kind of arthritis called psoriatic arthritis. Now, Pfizer’s Xeljanz got a label extension to treat ulcerative colitis (UC), a condition known to affect a huge population, almost 900,000 US people. Pfizer taps a substantial new market that can help up the sales.

Xeljanz, a leading brand for Pfizer, has been witnessing rapid growth. In the latest Q1, the drug saw a 19% growth in its sales in the US to $253 million. In 2017, the drug produced sales of $1.35 billion, and most of it came from the approval for psoriatic arthritis.

Now, Pfizer’s Xeljanz got a label extension to treat ulcerative colitis (UC), a condition known to affect a huge population, almost 900,000 US people.

The latest approval is based on the clinical studies performed, which showed the drug was effective in lowering the symptoms of the disease. Approved for adults, the recommended dose is 10mg twice a day to be taken for eight weeks.

Xeljanz will have to survive in a challenging and competitive market. The drug will have to compete against AbbVie’s (ABBV) blockbuster Humira, the top selling product of Johnson & Johnson (JNJ) Remicade, Shire’s (SHPG) Lialda, and other biosimilars.