Tremfya gets FDA approval for psoriatic arthritis

[Fred]

Tremfya has been given FDA approval to treat psoriatic arthritis.

Quote:

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Janssen announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® (guselkumab) for adult patients with active psoriatic arthritis (PsA), a chronic progressive disease characterized by painful joints and skin inflammation. TREMFYA is the first treatment approved for active PsA that selectively inhibits interleukin (IL)-23, a naturally occurring cytokine that is involved in normal inflammatory and immune responses associated with the symptoms of PsA. The safety and efficacy of TREMFYA in PsA have been demonstrated in two pivotal Phase 3 clinical trials. TREMFYA is administered as a 100 mg subcutaneous injection every eight weeks, following two starter doses at weeks 0 and 4. TREMFYA can be used alone or in combination with a conventional Disease Modifying Anti-Rheumatic Drug or DMARD (e.g., methotrexate).

The approval of TREMFYA was based on results from two pivotal Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which evaluated the efficacy and safety of TREMFYA administered by subcutaneous injection in adults with active PsA compared to placebo. The results showed that a significant percentage of patients treated with TREMFYA reached the studies' primary endpoint of ACR20a at 24 weeks, with 52 and 64 percent of patients achieving an ACR20 response compared to 22 and 33 percent in patients treated with placebo in DISCOVER-1 and DISCOVER-2, respectively.

In addition, treatment with TREMFYA improved patients' symptoms, which included skin manifestations of psoriasis, physical functioning as measured by the HAQ-DI (Health Assessment Questionnaire Disease Index)b and SF-36 Physical Component Summaryc score, and soft tissue (enthesitis and dactylitis). TREMYFA also resulted in improvement in fatigue as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F).

Source: janssen.com

Tremfya (guselkumab)

[jiml]

Fred as you have been using it for several months now, was it prescribed for psoriasis ? As I know you are enjoying it working on the psoriatic arthritis
Is it approved in  Europe yet for psoriatic arthritis  ?

[Fred]

Fred as you have been using it for several months now, was it prescribed  for psoriasis ? As I know you are enjoying it working on the psoriatic arthritis
Is it approved in  Europe yet  for psoriatic arthritis  ?

Hello Jim, it is only prescribed for psoriasis in France at the moment. But as I have a good relationship with my dermatologist we are trying it for both psoriasis and psoriatic arthritis. 

So far yes I'm pleased, it's not as good as Cosentyx but I think it needs a longer try than 6 months to be sure.

France is always behind the USA and EU recommendations, but I think from my own experience it will soon be getting EU approval.

[jiml]

Hopefully it will get EU approval following in from the US approval. I'm not sure when or if NICE will approve it for the UK

[Fred]

Hopefully it will get EU approval  following in from the US approval. I'm not sure when or if  NICE will approve it for the UK

I don't think they have worked out yet how they will approve new treatments next year. They may just follow the FDA or the EU, or will have to use their own approval system.

They like all EU members have their own approval system in place, for example even when the EU approve a treatment France drag their heals over getting it in the pharmacie.