Pfizer's Arthritis Drug Gets FDA Nod for Ulcerative Colitis

An image of a stock chart displayed on a tablet Credit: Shutterstock photo

Pfizer Inc.PFE announced that the FDA has approved the label expansion of its JAK inhibitor, Xeljanz (tofacitinib), to include a new indication - moderately to severely active ulcerative colitis ("UC"). The drug is approved for the treatment of adult patients with recommended a dose of 10 mg twice-daily for at least eight weeks.

The approval was expected as the FDA Gastrointestinal Drugs Advisory Committee had adopted a positive vote in a meeting in March recommending the approval of the supplemental new drug application (sNDA) filed in July last year seeking label expansion of Xeljanz in UC.

Xeljanz is already marketed for the treatment of rheumatoid arthritis and active psoriatic arthritis. In the first quarter of 2018, Xeljanz sales were $326 million, up 30.4% from the year-ago period. The label expansion in the UC indication is likely to boost its sales further.

Shares of Pfizer have lost 0.5% so far this year, compared with a 6% decrease for the industry it belongs to.

Pfizer is currently evaluating Xeljanz in an open label long-term extension study, OCTAVE Open.

However, there are several blockbuster drugs in the inflammatory segment approved for UC, which includes Johnson & Johnson's JNJ Remicade and Simponi, AbbVie's ABBV Humira and Shire's SHPG Lialda. Moreover, many biotech companies are developing their candidates for the treatment for UC. Hence, competition is likely to increase in this segment.

Pfizer Inc. Price

Pfizer Inc. Price | Pfizer Inc. Quote

Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

Will You Make a Fortune on the Shift to Electric Cars?

Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.

With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.

It's not the one you think.

See This Ticker Free >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

Pfizer Inc. (PFE): Free Stock Analysis Report

Johnson & Johnson (JNJ): Free Stock Analysis Report

AbbVie Inc. (ABBV): Free Stock Analysis Report

Shire plc (SHPG): Free Stock Analysis Report

To read this article on click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

More Related Articles

Sign up for Smart Investing to get the latest news, strategies and tips to help you invest smarter.