Pfizer will have to wait a little longer until it hears from the FDA regarding its application to market tofacitinib, a new orally-active drug candidate for rheumatoid arthritis.
The pharma company said yesterday that the FDA had extended the deadline for reviewing tofacitinib by three months because new data added into the dossier recently "constitute a major amendment to the application".
It said earlier this month that a delay was expected by a request for more data, but has confirmed that no new studies will need to be carried out to meet that requirement, with the FDA's new action date set at November, 21.
It also said its marketing applications for the drug in the EU and Japan remain on track.
Tofacitinib is an important new product for Pfizer as it continues to cope with the loss of patent protection for cholesterol drug Lipitor (atorvastatin) last year.
It is the first in a new class of disease-modifying RA drugs called Janus kinase (JAK) inhibitors that block the action of signalling proteins involved in inflammation. An FDA advisory panel gave its backing to the drug in May, setting it up to become the first new oral disease-modifying anti-rheumatic drug (DMARD) to reach the US market in more than a decade.
Initially being developed for moderate-to-severe RA, Pfizer also has trials running in other diseases such as psoriasis, inflammatory bowel disease and renal transplant, as well as a topical formulation in trials for psoriasis and dry eye disease.
Analysts have predicted that it could become a major earner for Pfizer, with sales upwards of $2bn a year at peak, offering an oral alternative to widely-used biologic therapies for RA, such as Abbott's Humira (adalimumab), Johnson & Johnson's (J&J) Remicade (infliximab) and Pfizer's Enbrel (etanercept) .
"We believe that the results from the comprehensive multi-study clinical development programme for tofacitinib have demonstrated a favourable benefit-risk profile," commented Yvonne Greenstreet, head of Pfizer's specialty care medicines development group.
"We remain committed to working expeditiously with the FDA to make tofacitinib available to patients," she added.