New data for Pfizer arthritis pill
pharmafile | September 18, 2012 | News story | Research and Development, Sales and Marketing | JAK, Pfizer, RA, tofacitinib
Pfizer is to release more data for its investigational rheumatoid arthritis (RA) pill tofacitinib which it hopes will demonstrate its efficacy and safety.
Tofacitinib, a first-in-class Janus kinase (JAK) inhibitor, is seeking a licence for the treatment of adults with moderate-to-severe active RA, a chronic inflammatory autoimmune disease.
If approved it would be the first new oral disease-modifying anti-rheumatic drug (DMARD) for RA in more than ten years. There are 23 million RA sufferers worldwide, most of whom find their hands and feet affected, although other joints can become inflamed too.
The presentations will be made at November’s American College of Rheumatology/Association of Rheumatology Health Professionals 2012 Annual Meeting in Washington, D.C.
They include ongoing Phase III study ORAL Start data which shows tofacitinib monotherapy to be superior to methotrexate (MTX) when it comes to inhibiting structural damage and in reducing signs and symptoms of RA.
Results from a two-year analysis of completed Phase III study ORAL Scan will also be presented, involving patients with moderate-to-severe active RA who had an inadequate response to MTX.
These show that patients taking tofacitinib maintained improvements including reductions in signs and symptoms, less damage to tissue and improvements in physical function.
Safety has been a concern: last year Pfizer reported four deaths in a study of tofacitinib, and the safety investigator said that one of these deaths was attributable to Pfizer’s drug.
However, a pooled analysis of two long-term, open-label extension studies – again to be presented at the ACR/ARHP conference in November – shows that patients with moderate-to-severe RA who had been in randomised Phase II or III studies of tofacitinib showed a consistent safety profile over 48 months.
Safety and efficacy were similar for patients receiving tofacitinib as monotherapy or with background nonbiologic DMARDs.
Pfizer argues strongly that more treatments are needed for RA since up to a third of patients do not adequately respond and about half stop responding to any particular DMARD within five years.
Last month the FDA held up tofacitinib by asking for more information but the US regulator did not ask Pfizer for any new studies, and expects the new review date to be 21 November.
The drug is also currently under regulatory review in Europe and Japan. Analysts say tofacitinib could hit peak sales of $2-3 billion a year – a welcome boost as Pfizer tries to offset losses from its off-patent brand Lipitor.
The signs are promising: tofacitinib matched Abbott’s Humira in a Phase III trial earlier this year and has previously done better than MTX in a head-to-head trial.
The main competitors – Humira, Pfizer and Amgen’s Enbrel and Janssen’s Remicade – are all making blockbuster sales in the injectable class, but tofacitinib may have an edge as it comes in pill form.
Adam Hill
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