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US Decision on Pfizer Rheumatoid Arthritis Pill Delayed Three Months

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The big drug maker says FDA isn't requiring new studies. The pill would compete with injected treatments such as Abbott's Humira.

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MINYANVILLE ORIGINAL Investors will have to wait a bit longer to find out whether Pfizer's (PFE) rheumatoid arthritis pill is ready to hit the market. The drug, considered a potential blockbuster by some analysts, was facing a Food and Drug Administration approval decision Tuesday, but that ruling will be pushed to November 21.

While delays can be nerve-racking for investors, Pfizer said the agency isn't asking for any additional studies, which is positive for potential approval. The reason for the delay, according to the company, is to allow the FDA to review recently submitted data.

Tofacitinib may exceed $2 billion in annual sales by 2018, according to estimates from Leerink Swann analyst Seamus Fernandez. The drug is unique because it would be the first oral medicine to compete with the standard injected products such as Abbott Laboratories' (ABT) Humira, Amgen's (AMGN) Enbrel, and Johnson & Johnson's (JNJ) Remicade. Pfizer is studying the treatment for other inflammatory conditions as well, and the company is seeking the medicine's approval for rheumatoid arthritis in Europe and Japan.

Shares of Pfizer fell less than 1% to $23.81 in early trading Tuesday. The stock is up 10% this year. Abbott, which is splitting into two companies by the end of the year, is up more than 17% since January. Pfizer, which has been doing its own corporate reengineering, has been up and down this year.

In May, a panel of expert advisers to the FDA backed Pfizer's drug, saying its benefits merit approval. The advisers, however, debated safety concerns about the drug after a review of the medicine by FDA staff.

Pfizer needs new drugs to offset lost sales to generic competitors after patent expirations on former top-selling products such as Lipitor. News hasn't been good for the big drug maker as of late. In June, Pfizer and partner Bristol-Myers Squibb (BMY) were dealt a surprise setback when the FDA rejected their stroke-prevention drug Eliquis, another medicine seen as a potential big-selling product. (See Pfizer, Bristol-Myers Dealt Approval Setback on Blood Thinner Eliquis.)

Earlier this month, Pfizer, J&J, and Elan (ELN) said they were discontinuing a program to test the drug bapineuzumab for Alzheimer's disease.

Twitter: @brettchase

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