Pfizer’s RA drug on course for approval
pharmafile | May 10, 2012 | News story | Sales and Marketing | Humira, JAK inhibitor, Pfizer, RA, rheumatoid arthritis, tofacitinib
An FDA advisory committee has recommended for approval Pfizer’s new rheumatoid arthritis treatment tofacitinib.
The Arthritis Advisory Committee voted 8-2 to recommend approval of the drug for adult patients with moderately to severely active rheumatoid arthritis (RA). This recommendation now looks likely to lead to a full approval, which is expected in August.
Pfizer hopes the drug could eventually become the first choice drug for treating RA, and topple Abbott’s current market leader Humira.
Analysts say tofacitinib could hit peak sales of $2-3 billion a year.
If approved, tofacitinib would be the first new oral disease-modifying anti-rheumatic drug (or DMARD) for RA in more than 10 years, and the first in a new class known as Janus kinase (JAK) inhibitors.
Its easy oral administration should make the drug more attractive for doctors and patients, and was boosted by a recent head-to-head Phase III trial where it matched Humira in efficacy.
Abbott’s Humira leads the pack of injectable drugs which includes Pfizer/Amgen’s Enbrel and J&J’s Remicade, but a pill with the same level of efficacy has obvious attractions to doctors and patients.
“We are pleased with the Committee’s positive evaluation of the tofacitinib data and its decision to recommend approval,” said Dr Yvonne Greenstreet, senior vice president and the head of Medicines Development Group for Pfizer Specialty Care.
“The RA patient population needs additional treatment options, and Pfizer looks forward to working with the FDA on next steps as it completes its review of the tofacitinib application.”
Tofacitinib
While Humira and other TNF alpha blockers are directed at extracellular targets such as pro-inflammatory cytokines, tofacitinib takes a novel approach targeting the intracellular pathways that operate as hubs in the inflammatory cytokine network.
Tofacitinib has been evaluated in around 4,800 patients yielding 7,000 patient-years of exposure in a comprehensive, global clinical development programme that included five pivotal Phase III trials and two ongoing long-term extension studies in 45 countries.
The drug is also currently under review in Europe and Japan.
Andrew McConaghie
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