Otezla gets FDA approval for Psoriatic Arthritis

[Fred]

Apremilast is now known as Otezla after getting FDA approval for psoriatic arthritis.

Quote:

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Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA® (apremilast), the Company's oral, selective inhibitor of phosphodiesterase 4 (PDE4), for the treatment of adult patients with active psoriatic arthritis.

"OTEZLA works differently from other therapies approved for psoriatic arthritis through the intracellular inhibition of PDE4," said Philip Mease, MD, Director of the Rheumatology Clinical Research Division of Swedish Medical Center and Clinical Professor, University of Washington. "The approval of an oral therapy with a novel mechanism of action for patients with psoriatic arthritis offers a different approach to patient care."

The approval was based on safety and efficacy results from three multi-center, randomized, double-blind, placebo-controlled trials.

"Patients and physicians have expressed their desire for a safe and effective therapy for psoriatic arthritis that has the potential to simplify patient management. Celgene is excited to be expanding our transformational science into the therapeutic realm of Inflammation and Immunology, with a new approach for patients with psoriatic arthritis," said Scott Smith, Global Head, Inflammation and Immunology, Celgene Corporation. "The FDA approval of OTEZLA is good news for patients and healthcare professionals who are looking for a different way to manage this disease."

OTEZLA® (apremilast) is expected to be available in the U.S. in March 2014 and will be dispensed through a comprehensive network of specialty pharmacies. For more information about OTEZLA distribution and the exclusive treatment support services (including reimbursement assistance and 24/7 nurse support), doctors and patients can contact Otezla SupportPlus™ at 1-844-4OTEZLA (1-844-468-3952) or visit [web]www.OTEZLA.com[/web] for more information.

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You can read about the studies here: Apremilast first phase 3 results

[mataribot]

I saw my dermatologist today. He recommend that I try this for PsA since Stelara isn't working as well as I hoped for joint pain. Unfortunately, I would have to give up Stelara to try this. The dosing is strict and similar to birth control pills. The Approximate cost is 23000 USD yearly or approximately 12000 USD less than the standard dose of Stelara.

[Fred]

I saw my dermatologist today. He recommend that I try this for PsA since Stelara isn't working as well as I hoped for joint pain. Unfortunately, I would have to give up Stelara to try this. The dosing is strict and similar to birth control pills. The Approximate cost is 23000 USD yearly or approximately 12000 USD less than the standard dose of Stelara.

I can understand your reluctance to stop Stelara as I was once asked about going onto a trial and had to wait a while. It was horrible after being clear for a few years then suddenly psoriasis starts coming back when you stop, in the end I didn't go on the trial and went back on to Stelara.

In your case I would say give it a try, the Stelara is not helping you enough and you can always switch back if you want at any time.

If you do go for it please feel free to start a new thread in Prescribed Treatments For Psoriasis and share your experience as it could help others.

Good luck with you choice.

[jiml]

I wish you good luck with the change over, have they said how long you will have to wait after you come off Stelara before they will start the new drug.
It's got to be worth a try as you have reported Stelara is not doing the job..
I have my fingers crossed that you will soon get some long term relief

[Caroline]

I can only add my good luck wishes to those of Fred and Jim, Mataribot.
I really hope this works for you.

Caroline

[mataribot]

Apparently, I can take this drug whenever. However, he wants me to talk to Rheumatologist first. That appointment is on 30th.

[jiml]

Great news here's to success