Please login to the form below

Not currently logged in

Pfizer set to file Xeljanz for psoriasis

Set to add another indication after positive study results
Pfizer headquarters

Pfizer looks set to add a lucrative new indication for its fast-growing arthritis treatment Xeljanz after more positive data in psoriasis.

The results of the OPT Pivotal #1 and OPT Pivotal #2 trials showed that the Janus kinase (JAK) inhibitor, given at a dose of 5mg or 10mg twice-daily, was significantly more effective than placebo in clearing psoriasis lesions after 16 weeks' treatment.

Pfizer has not yet revealed details of the new data, but said it now plans to press ahead with a regulatory filing for Xeljanz (tofacitinib) in the US by early 2015, in the hope of adding to its current approved use in moderate-to-severe rheumatoid arthritis.

Last October Pfizer reported data from a phase III trial (OPT Compare) which showed that Xeljanz was as effective as Pfizer's own blockbuster Enbrel (etanercept) when given at a 10mg dose to patients with moderate-to-severe chronic plaque psoriasis, although the 5mg dose did not meet the criteria for non-inferiority.

In another trial - OPT Retreatment - Xeljanz met the primary efficacy endpoints at both doses, showing that a greater proportion of patients continuing Xeljanz treatment maintained their response during the treatment-withdrawal phase compared to patients who switched to placebo.

Xeljanz has got off to a reasonable start for Pfizer since its launch in 2012, adding $114m to the company's coffers in 2013. Its take-up has been held back by the FDA's decision to approve only the 5mg dose - saying the 10mg dose was not considered to have an adequate risk-to-benefit ratio - as well as Pfizer's failure to secure its approval in Europe.

Xeljanz had once been tipped as a $3bn-a-year blockbuster, but the knockbacks in the US and Europe have led analysts to scale down their expectations to around $1bn, at least in the near-term.

As an oral therapy Xeljanz could gain some upside from approval in moderate-to-severe psoriasis, although it could face stiff competition from entrenched therapies such as Enbrel, AbbVie's Humira (adalimumab) and Johnson & Johnson's Remicade (infliximab).

"Psoriasis is a long-term disease with no cure that can have a significant impact on patients," said Steven Romano, global medicines development lead at Pfizer.

Xeljanz has the potential to become "an important new treatment option for adults with moderate-to-severe chronic plaque psoriasis," he added.

Article by
Phil Taylor

23rd April 2014

From: Sales



Featured jobs

Subscribe to our email news alerts


Add my company
infill healthcare communication

infill is a dynamic and innovative, international healthcare agency with >25 years' experience in delivering healthcare communication, medical education and...

Latest intelligence

PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...
What Would Jeremy Do? : Assessing the impact of a Corbyn-led Labour government
GK Strategy are delighted to announce the launch our latest briefing paper entitled ‘What Would Jeremy Do? Assessing the impact of a Corbyn-led Labour government’....