FDA accepts Pfizer’s arthritis pill for review
pharmafile | December 22, 2011 | News story | Research and Development, Sales and Marketing | FDA, Pfizer, tofacitinib
The FDA has accepted Pfizer’s novel arthritis pill tofacitinib for review, and could be on the US market next year.
The drug is an investigational novel, oral JAK inhibitor for the treatment of patients with moderately to severely active RA.
The US firm has also submitted an application for this indication for tofacitinib to regulatory authorities in Japan. In November, the EMA accepted the drug for review for patients with moderate-to-severe active RA.
It is forecast to bring in peak annual sales of $2.6 billion, but will be competing in a crowded market.
Current treatments include Abbott’s Humira, which brought in sales of over $6 billion last year, J&J’s Remicade and Pfizer/Amgen’s Enbrel.
These treatments are all injectable, whereas Pfizer’s pill could become more attractive due to the ease in its administration.
Three biotechnology companies are trying to catch up to Pfizer with similar treatments that target the JAK protein: including Rigel, Incyte and Vertex – but their drugs are all at a much earlier stage than tofacitinib.
Geno Germano, president and general manager of specialty care and oncology at Pfizer, said: “Pfizer is pleased to have achieved this regulatory milestone, which reflects our commitment to advancing treatments for inflammatory conditions, and constitutes a significant step toward bringing tofacitinib to RA patients who are in need of additional therapeutic options.
“We are proud of the comprehensive Phase III clinical programme that we have completed and believe that, if approved by the FDA, tofacitinib has the potential to improve the lives of people with RA.”
Despite the filings, Pfizer’s drug has had an up and down year. In September, tofacitinib impressed analysts when its matched Humira in a Phase III head-to-head study.
But in April four patients died whilst being treated with the drug, with one patient’s death potentially related to use of the drug.
Ben Adams
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