Pfizer: Five more countries OK arthritis pill Xeljanz

by Linda A. Johnson

Several more countries have approved Pfizer Inc.'s new rheumatoid arthritis medicine, a twice-a-day pill seen as likely to be a big moneymaker for the company.

The world's second-largest drugmaker said Monday that its Xeljanz has been approved, for patients not adequately helped by existing treatments, in Russia, Argentina, Kuwait, the United Arab Emirates and Switzerland, the first European country to allow sales.

Xeljanz, the first in a new class of drugs for the joint-damaging immune disorder, was launched in November in the U.S., where it has been heavily advertised. It's about to be launched in Japan, where it was approved in March. But concerns over serious, though generally rare, side effects including cancer have blocked approval in Europe so far.

New York-based Pfizer has been hoping to win over patients who either just take or are being treated with injected biologic drugs meant to slow or stop progression of moderate to severe rheumatoid arthritis. The biologic drugs, which are produced in living cells rather than by mixing chemicals together, include Enbrel, Humira and Remicade.

All three have been blockbusters for years, because they are approved for treating multiple and are very pricey. Each was among the world's top six drugs by revenue last year, and their combined sales for all uses totaled about $23 billion.

According to Pfizer, the wholesale price for a month's supply of Xeljanz is about $2,055; the retail price likely would be higher. The three biologic drugs cost roughly $2,500 per month.

Humira is sold by AbbVie Inc., Remicade by Johnson & Johnson and Merck & Co., and Enbrel by Amgen Inc. and Pfizer.

Meanwhile, Pfizer is asking advisers to European Union medical regulators to reconsider their recommendation in April not to approve the drug.

The advisers said Xeljanz didn't control progression of the immune disorder enough to outweigh serious side effects seen in some patients. Those include blood and other cancers, perforated intestines, tuberculosis and other infections, decreased infection-fighting cells, headaches and diarrhea.

Nearly 24 million people worldwide suffer from , a painful, often disabling immune disorder. Many aren't satisfied with current treatments.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Xeljanz approved for rheumatoid arthritis

Nov 07, 2012

(HealthDay)—Xeljanz (tofacitinib) has been approved by the U.S. Food and Drug Administration to treat symptoms of rheumatoid arthritis (RA) among people who can't tolerate, or haven't been helped by, the drug methotrexate.

Pfizer says patient died in oral RA drug study

Apr 22, 2011

(AP) -- Pfizer Inc. confirmed that one patient who was taking its drug candidate tofacitinib, a pill designed to treat rheumatoid arthritis, died during a recent clinical trial and said the death was connected to the drug.

Bristol-Myers, Pfizer's Eliquis approved in Japan

Dec 26, 2012

Regulators in Japan have approved sales of an anticlotting drug called Eliquis, developed by Bristol-Myers Squibb Co. and Pfizer Inc., that's a potential blockbuster in a new category of medicines to prevent strokes and heart ...

Recommended for you

Boxed warnings are common in novel therapeutics

Aug 19, 2014

(HealthDay)—Boxed warnings are common on recent drug approvals, and many occur years after approval, according to a research letter published online Aug. 15 in JAMA Internal Medicine.

AstraZeneca says DOJ closes probe into drug trial

Aug 19, 2014

British drugmaker AstraZeneca says the U.S. Department of Justice has closed its investigation into a clinical trial of the company's blood thinner Brilinta, and plans no further action.

Perampanel for epilepsy: Still no proof of added benefit

Aug 19, 2014

The drug perampanel (trade name Fycompa) has been approved since July 2012 as adjunctive ("add-on") therapy for adults and children aged 12 years and older with epileptic fits (seizures). In a new early benefit assessment ...

User comments