Pfizer’s arthritis pill delayed by FDA

Hannah Blake

pharmaphorum

Pfizer’s bid to bring a new rheumatoid arthritis pill to the market has been delayed by up to three months by the US Food and Drug Administration (FDA). This move was expected, as the US regulator requested Pfizer to submit extra information, following the company’s New Drug Application (NDA) of tofacitinib, which will take additional time to review.

Tofacitibib is an investigational oral treatment for adults with moderately to severely active rheumatoid arthritis. The original approval date for the drug was scheduled to be the 21st August, but the FDA now has until the 21st November to decide.

“RA patients are in need of additional treatment options to help fight this serious chronic inflammatory autoimmune disease. We believe that the results from the comprehensive multi-study clinical development program for tofacitinib have demonstrated a favorable benefit-risk profile, and we remain committed to working expeditiously with the FDA to make tofacitinib available to patients.”

Dr. Yvonne Greenstreet, senior vice president and head of the Medicines Development Group for Pfizer Specialty Care.

If approved, tofacitinib would be the first rheumatoid arthritis treatment in a new class of medicines known as Janus kinase (JAK) inhibitors and the first new oral disease-modifying antirheumatic drug for rheumatoid arthritis in over 10 years.

EU-Clinical-Trial-Directive-Regulatory-Requirements-20Sep12

Related news:

Pfizer’s Experimental Arthritis Pill Delayed By 3 Months (Bloomberg Business Week)

Pfizer Says FDA Extends Action Date For Tofacitinib NDA By 3 Months (RTT News)

Reference links:

Pfizer

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