Germany says Cosentyx shows no added benefit for psoriatic arthritis.

[Bill]

I fully sympathise with your desire to get what you believe to be the best treatment and your frustration with bureaucracy: That is why I self-medicate. But regulation is for the purpose of protecting people. Just look at all the sharks and charlatans in the unregulated alternative medicine sphere. Also note that Fred has set up Psoriasis Club to allow members to share treatment experiences. The forum would not be what it is without regulation to keep out the con artists.

[mataribot]

Even Japan had approved this drug for PsA. Wonder who thr odd ball is - I really don't have to say anything else.

[Bill]

They were asked for evidence and provided none. If they think themselves hard done by they can take the regulator to court, or at least they can do that in Australia.

[mataribot]

they were asked an irrelevant question. The TNFs are not the gold standard anymore. Stelara is. There is enough evidence to support that Cosentyx helps with PsA and AS. Does help as well as TNFs? Why does this matter? Cosentyx is something to be tried after thr TNFs fail. From my use of the drug I am guessing that doesn't work as wll as TNFs for hands and feet, but as good as or slightly better for thr back. However, it's significantly more stable than the TNFs.

I really don't understand they logic of requesting them to do a study against a TNFs. Makes no sense.

[Fred]

I really don't understand they logic of requesting them to do a study against a TNFs. Makes no sense.

You may think it makes no sense and I agree with you. But the point is that they have failed to deliver what was requested from a regulatory board. They have their reason for asking for the information and the drug maker must conform if he wants to get approval. It's as simple as that and we are not privy to their reasons but a drug manufacturer must conform to requests what ever they are.

[mataribot]

it's an excuse and poor setup. They are requesting information they don't have or are currently in trial for and they know that.

[Bill]

If tnfs are no longer the gold standard then the company has been set an easier task. And while it is true that bios fail, is it not also true that other bios are available in Germany? My belief is that DMF as I take it is the gold standard for p and psa, yet I have no expectation that anyone should accept an unsupported claim.

[mataribot]

.done i am done

[Caroline]

If tnfs are no longer the gold standard then the company has been set an easier task. And while it is true that bios fail, is it not also true that other bios are available in Germany? My belief is that DMF as I take it is the gold standard for p and psa, yet I have no expectation that anyone should accept an unsupported claim.

I'll accept it.