Pfizer’s arthritis drug delayed by FDA
pharmafile | August 21, 2012 | News story | Research and Development, Sales and Marketing | FDA, Pfizer, tofacitinib
Pfizer says its new rheumatoid arthritis drug tofacitinib has been delayed by the FDA.
Tofacitinib, an oral Janus kinase (JAK) inhibitor, is seeking a licence for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).
The drug was filed with the FDA earlier this year, but the Agency recently asked Pfizer for more information about the drug. The FDA determined that additional data analyses recently submitted by Pfizer constitute a major amendment to the application and will require three extra months to review the drug.
The FDA has not asked Pfizer to complete any new studies – it expects the drug’s new review date to be 21 November, exactly three months after its original 21 August date.
Pfizer will hope the FDA will not take too long to review the new information as analysts say tofacitinib could hit peak sales of $2-3 billion a year, and the firm will want to realise these sales as soon as possible.
Dr Yvonne Greenstreet, senior VP and head of the medicines development group for Pfizer Specialty Care, said: “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,” she added.
The drug is also currently under regulatory review in Europe and Japan.
Competition
If approved, tofacitinib would be the first new oral disease-modifying anti-rheumatic drug (or DMARD) for RA in more than ten years, and the first in a new class known as JAK inhibitors.
Pfizer has chalked up success against in a head-to-head trial with methotrexate, but tofacitinib’s real competition will come from Abbott’s Humira, Pfizer and Amgen’s Enbrel and Janssen’s Remicade – all of which are making major blockbuster sales.
But these drugs are all injectable – Pfizer may have an edge as it comes in a pill form, making administration easier.
Pfizer also received a boost earlier this year when its drug managed to match Humira in a head-to-head Phase III trial.
Safety concerns
Last year Pfizer reported four deaths in one of its studies of tofacitinib and the safety investigator said that one of these deaths was attributable to Pfizer’s drug.
But in this new study, the firm said no new safety signals emerged, and Pfizer is confident that this was an isolated event.
Ben Adams
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