Posted by jrbecker on April 11, 2006, at 23:48:50
In reply to Re: agomelatine (Valdoxan) - Application to FDA?, posted by ravenstorm on April 11, 2006, at 22:08:41
To try to clear up someof the confusion, I thought I'd offer a little more info about the current situation.
The good news is that the recent press release about Novartis buying the U.S. licensing rights for Agomelatine means that European approval is quite optimistic.
Bad news...here in the U.S., Novartis will have to do further Phase III (and possible Phase II) trials to pass specific FDA standards before approval. Novartis should be revealing a clinical trial design sometime within the next few months that will hopefully highlight an eventual application timeframe.
Back the European picture, the drug was submitted to the European Medicines Evaluation Agency (EMEA) for review in April 05. Although the EMEA review timeframe can vary considerably, the current average response time this year is approximately 12months....meaning we could even see a response later this month, but possibly not til summer or later. BUT, the EMEA response doesn't mean final market approval. In reviewing drug applications, the EMEA issues either a "positive" or a "negative" opinion. If it's positive, then the EMEA then forwards on the application to the European Commission (EC) for official approval. This is known as the post-opinion phase, which takes approx 40-50 days for filing. Then, the EC decision process actually takes 50-70 days. So, all this means that even if the EMEA gives a positive opinion later this month (April), the EC probably won't approve it officially until the earliest, August. Lastly, the pharm company won't probably get the product on the market until at least 1-2 months later. And that's in the swiftest circumstances. I think fall or even winter 2006 is just as likely.
For more info on Average European average drug review timelines, see below.
European Drug Approval Timeframes:
2005 Average timeline (preliminary results as of MARCH mtg, out of 28 reviewed products)
Assessment phase: 201 days
*Clock-stop: 161 days
Post-opinion phase: 46 days (2004 avg)
Decision process: 56 days (2004 avg)=464 days (15 months)
2004 Average timelines:
Assessment phase: 210 days
*Clock-stop: 123 days
Post-opinion phase: 46 days
Decision process: 56 days= 435 days (14.5 months)
Last 3 year’s Average timelines:
Assessment phase: 208.3 days
*Clock-stop: 214.3 days
Post-opinion phase: 40.6 days
Decision process: 66.3 days= 530 days (17.6 months)
*the clock is stopped during the review process for the company to address issues brought up during scientific review.
poster:jrbecker
thread:479920
URL: http://www.dr-bob.org/babble/20060408/msgs/632028.html