Could it be? Is teh FDA finally getting common sense? If a drug shows some efficacy and is safe, approve it then let the market decide? And continue your trials?
The FDA just approved Seatlle Genetics (SGEN) cancer drug. What is amazing is that the approval came from only TWO trials One was 102 patients, the other 58. They both were SINGLE ARM trials. There was no PLACEBO! Give the drug. If it is safe and works, approve it...but they must do a larger trial to confirm. But in meantime, you mat sell it. Read the FDA release:
The FDA seems to have speeded approval because there hasn't been any new drug for these lymphoma cancers. SOUND FAMILIAR??? There is only ONE approved drug for Dry EYE and there has been no others approved..and dry eye is a large problem. Is FDA listening better now??? I think that the FDA will keep an open mind on TB 4 in this trial. I do not think they will fail te trial if these comfort measures show that placebo drops make your eye more comfortable. OF COURSE THEY WILL make you more comfortanle! Adding drops of ANY lubricant to dry eye eill make you feel more "comfortable"! Still, it could be an issue. But if TB 4 can only get a large % response rate than restasis, and shwo show no safety or side effect issues.....the comfort measures will be overlooked. because there are no other dry eye therapies. Look ehat the FDA did for lymphoma drug because there was no new drug. Approved on 158 patients trial. WITH NO PLACEBO!
Hey, don't get me wrong. Don't care how SGEN pulled it off. I am just amazed....that the FDA gave an okay to sell a drug based on two studies that totalled only 150 patients...and neither trial used a placebo control aspect. It is unheard of by teheDA I only show it because it could have positive effect on RGRX, should ANY of it's trials show something good. we're not there yet. But consider the EB trial. There is no drug for EB. It has taken RGRX about 6 years to do the trial. Patients are hard to get. Compare what the FDA did for SGEN. In EB the approval bare is so low....if there is ANY kind of decent efficacy... with safety....the parents will be rioting for it, and I think the FDA will oblige. I think a good chance RGRX tries for approval, if phase 2 is good. But I can't get too hopeful. Common sense butts in and says what are the odds of a trial taking 6 years to do? Only 36 patients? Word would have spread if something good was seen. PAtients would have been easier to get. Ughhh.
But this SGEN news is good for Dry Eye area too! That is a 75 patient placebo controlled trial. Dry eye is a large problem. There is only one drug for Dry Eye. It gets about 15% response. It has side effects. It is not a great drug in those senses. It sells $700 million a year. I have tp think that if another dug comes along and ups the response rates over restasis.... and does so with no side effects/safety issues..what will the FDA do? Reject it...over some comfort plavebo measure??? Patients and doctors will scream bloddy murder. We need teh efficacy show dry eye. 30% plus of response rates woudl be a great start. Who knows.