Pfizer’s RA pill impresses in Phase III
pharmafile | August 1, 2012 | News story | Research and Development, Sales and Marketing | FDA, JAK, Pfizer, RA
Pfizer’s investigational arthritis drug tofacitinib has beaten methotrexate in a head-to-head study.
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 new ORAL Start study, which randomised patients to receive tofacitinib 5 or 10 mg twice-daily (BID) as monotherapy or MTX, met its primary endpoints at both the 5 and 10 mg doses.
Tofacitinib was found to be superior to MTX with statistically significant changes shown in inhibiting structural damage at six months. This was measured by change from the baseline in modified Total Sharp Score, and in reducing signs and symptoms of RA, as measured by ACR70 response rates.
The drug was filed with the FDA earlier this year, but the Agency has recently asked Pfizer for more information about the drug.
Approval was expected on 21 August, but the firm said it would now be supplying the FDA with additional analyses, which means it is unlikely to see a regulatory decision until later in the year.
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 to 3 billion a year, and the firm will want to realise these sales as soon as possible.
The drug is also currently under regulatory review in Europe and Japan.
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 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
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
