Delay In FDA Approval for HAE Treatment

31 Jan

FDA approval of Cinryze, the Lev Pharma C1 Inhibitor concentrate currently undergoing drug trials here in the US, was originally anticipated for early 2008. That anticipated approval has now been moved to sometime in the June 2008 time frame. I’ve been participating in drug trials for this type of treatment (C1 INH) since 1990 and I’m definitely impatient, but at least the grail is now in sight! Dear Goddess, please do not let the FDA disapprove this treatment a second time.

Dear HAE Friends,

Lev Pharmaceuticals-the company working to get C1 inhibitor concentrate licensed in the United States–today announced that the FDA is requesting additional analysis on (1) data gathered for its acute attack and prophylaxis (attack prevention) clinical trials, and (2) certain aspects of the product’s manufacturing process.

While we wish that the FDA would have simply gone ahead and given the company an approval, today’s action is a typical step in the drug licensing process. Lev Pharmaceuticals officials said that the FDA’s request is reasonable and that the Company is confident that they can provide a response to successfully deal with the issues raised. The good news is that Lev executives believe approval will be granted in the June timeframe.

The HAE Association and our medical advisors will continue doing everything possible to support Lev and all the companies that are working to get their products approved. We plan to attend meetings with the FDA to impress upon them the critical need for an effective and safe treatment for both treating and preventing HAE attacks. In addition, if the FDA decides to establish an Advisory Committee to evaluate Lev’s licensing application, we will be there to advocate for swift approval.

In the meantime, Lev Pharma will continue providing open label access to HAE patients that participated in their clinical trial. The HAE Association has asked the Company to expand the patient access program to provide this life saving medicine to as many patients as possible.

On several occasions over the past 6 years, the HAE Association has sponsored letter writing campaigns to the FDA and congressional representatives. As a result of these efforts, we know that key FDA executives are aware of HAE, and that it constitutes a severe unmet medical need. From a strategy standpoint, since it appears quite likely that the Lev product will be approved in a few months, we do not believe the time is right for us to bombard the FDA or the Congress with letters. Of course, that sentiment could change as the situation unfolds.

We will keep you posted as more news becomes available.

Warm regards to all HAE friends,

Tony Castaldo
President, US HAE Association

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