Karela Fry

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What are you willing to risk in order to live without arthritis?

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Business Week implies that Pfizer’s new drug against rheumatoid arthritis is better than existing drugs, but can cause lots of other problems:

A late-stage study of Pfizer Inc.’s experimental drug for moderate-to-severe rheumatoid arthritis found it worked better than the standard treatment, Pfizer said Tuesday.

Pfizer released limited results of the study, called ORAL Start, of its tofacitinib. It’s a new type of drug to fight the painful chronic inflammatory disorder, in which the immune system attacks the body’s joints, particularly the hands and feet.

The ongoing two-year study, sponsored by Pfizer, compared two doses of tofacitinib with methotrexate in 958 adults not previously treated with methotrexate. Data from a planned interim analysis found that after six months of treatment, the half of study participants getting tofacitinib had fewer signs and symptoms of the disorder, as well as less structural damage, than those getting methotrexate.

The study has not revealed any additional safety problems with tofacitinib. Research to date shows it can cause tuberculosis, herpes and other serious infections; lymphoma and other cancers; decreased levels of infection-fighting white blood cells called neutrophils; and elevated levels of lipids, or molecules in the blood that include cholesterol, fats and waxes.

In May Fierce Biotech had commented on safety risks:

FDA staffers drew attention to safety risks associated with Pfizer’s blockbuster contender tofacitinib in briefing documents. The agency’s concerns come days before a panel of non-FDA experts delves into Pfizer’s application for approval of the oral med for rheumatoid arthritis.

Tofacitinib–which Pfizer hopes to establish as a rival to a host of multibillion-dollar RA treatments–offers the first oral drug of its kind to combat RA. But FDA staffers raised concerns about increased risks of malignant cancers–particularly lymphomas–and infections tied to the drug. As is common to such reviews, the agency staff questioned whether the benefits of the treatment outweighed the risks to patients, Reuters reported, and they critiqued the X-ray methodology that Pfizer used to measure efficacy.

WSJ in a report implies that these safety concerns have not gone away:

The U.S. Food and Drug Administration may take longer than expected to review Pfizer Inc.’s (PFE) application to market a new treatment for rheumatoid arthritis, the drug maker’s chief said Tuesday.

The FDA has requested additional analysis of clinical data for tofacitinib, which Pfizer plans to provide in early August, Chief Executive Ian Read said on a conference call with analysts.

That could push the FDA’s decision beyond the targeted Aug. 23 decision date, Read said.

Tofacitinib has generally shown positive efficacy in prior late-stage clinical trials, with safety risks that analysts believe are consistent with certain existing treatments for rheumatoid arthritis.

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Written by Arhopala Bazaloides

August 1, 2012 at 4:43 am

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