FDA says no to Xeljanz for psoriasis

[Fred]

The FDA have turned down XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The US regulator sent Pfizer a Complete Response Letter stating that it would be unable to approve Xeljanz (tofacitinib) for psoriasis without additional information. It is thought to relate to the safety of the drug, and Pfizer have responded on their website.

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Pfizer Inc. announced it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The Agency provided recommendations specific to the moderate to severe chronic plaque psoriasis sNDA. Pfizer will work with the Agency to determine an appropriate path forward to address their comments, including providing additional safety analyses of XELJANZ for the proposed indication.

“Pfizer remains committed to XELJANZ based on the strength of the clinical data for the treatment of psoriasis,” said Kenneth Verburg, PhD, senior vice president and head of global medicines development, Global Innovative Pharma Business. “It is our goal to work closely with the FDA to understand and address their comments about our filing for the use of XELJANZ in patients with chronic plaque psoriasis.”

Source: pfizer.com

[jiml]

Hopefully Pfizer will find a way to saisfy the FDA and will push to get this drug on the market. We need as many options as possible

[Kat]

I read where Europe wouldn't approve it as an RA drug (which it's currently being used for) due to concerns about infection risks.

I guess Pfizer says data shows it's as effective as Enbrel in treating psoriasis.

I agree Jim, hope Pfizer can do what needs to be done to satisfy the FDA as new drugs are coming out now and the more choices we have, the better.

[mataribot]

The drug is dangerous and is expensive. I can see why they will not approve it.

[Fred]

The drug is dangerous and is expensive. I can see why they will not approve it.

Is the FDA like the UK NICE where they will not approve for cost reasons?

I didn't think the FDA would take cost into consideration, but safety does seem to be the reason they have said no.

[Kat]

The drug is dangerous and is expensive. I can see why they will not approve it.

Is it dangerous? I haven't heard of it until seeing Fred's post which had me looking up info on it. It looks like it's been being used to treat RA so has been approved for that. I thought it was that they needed more to show it was effective against psoriasis more so than any other factors. And I'm asking as I'm curious and looking for information not because I don't agree with you. I don't know enough about it to agree or disagree.

[Fred]

The drug is dangerous and is expensive. I can see why they will not approve it.

Is it dangerous?  I haven't heard of it until seeing Fred's post which had me looking up info on it.  It looks like it's been being used to treat RA so has been approved for that.  I thought it was that they needed more to show it was effective against psoriasis more so than any other factors.  And I'm asking as I'm curious and looking for information not because I don't agree with you.  I don't know enough about it to agree or disagree.

We posted at the same time Kat.

All I can find is that the FDA want more safety evidence, what that is I don't know. And like you I'm not disputing what Matari has said, but I haven't found anything that points to the exact problem about the safety issue.

[mataribot]

I got my info from my rheumatologist. He said it is one of his last choices. Did not explain why (besides it is dangerous), but said no when I asked. If you google you can find some issues with it.

[Fred]

I got my info from my rheumatologist. He said it is one of his last choices. Did not explain why, but said no when I asked.

Interesting. There seems to be something going on that we the public are not privy too.

[Fred]

Update:

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With competition heating up, Pfizer may drop psoriasis effort on Xeljanz

Earlier this month, the FDA slapped down Pfizer's Xeljanz as a treatment for moderate to severe cases of plaque psoriasis. And that could be the end of the line for the med in that indication, execs said Tuesday.

Pfizer will "reconsider" its investment in a psoriasis nod for Xeljanz following discussions with the FDA, CEO Ian Read told investors on the company's Q2 conference call. "We recognize that overcoming the issues raised" by the agency "may be difficult, especially in light of the evolving marketplace."

That marketplace includes a host of new psoriasis contenders coming up through Big Pharma's pipelines. Novartis' Cosentyx, the leader of the pack, won approval earlier this year, and Merck & Co. Johnson & Johnson, Eli Lilly and others have prospective meds that could soon prove tough contenders.

And in the meantime, Pfizer is nixing a couple of other development projects for Xeljanz, too, halting work with the drug in Crohn's Disease and ankylosing spondylitis. Novartis already has regulatory submissions out for Cosentyx in ankylosing spondylitis, an area where J&J is looking to compete with its Stelara, too. And Stelara--itself under fire from the new psoriasis competition--recently posted positive Phase III data in Crohn's patients who had failed first-line therapy.

Instead, Pfizer will be relying on Xeljanz' current indication--rheumatoid arthritis--plus psoriatic arthritis and ulcerative colitis to help the slow starter get going. Xeljanz has racked up just $351 million in sales through the first 9 months of this year, meaning it'll fall far from the blockbuster numbers industry watchers once predicted.

In ulcerative colitis, though, Pfizer has some promising data in hand. Two studies--OCTAVE 1 and 2--both met their primary endpoints, measured by the proportion of Xeljanz patients in remission after 8 weeks of treatment compared with patients on placebo, the company said last month. Those trials are part of a group of four expected to form a potential regulatory submission package for a UC nod.

And the drugmaker is still testing Xeljanz in RA, too; it's working on a head-to-head superiority study that pits the therapy against the world's best-selling med, AbbVie's Humira, Pfizer's pharma president, Geno Germano, told investors on the call. Pfizer expects to read out results in the first quarter of 2017.

Source: fiercepharmamarketing.com