Re: NEWS - Approval of Actemra (tocilizumab) delayed further

[Guest guest]

My doctor was telling me that when they unblinded the study, there were 11

deaths related to (if I remember correctly) cardiovascular in patients who

actually received the drug and not placebo.

He also told me that they did clinical trials at his office with great results

for this medication........

w] ~]ss Kami ss] ~]w

[ ] NEWS - Approval of Actemra (tocilizumab) delayed further

Roche hit as FDA seeks more data on arthritis drug

By Reid

ZURICH, Dec 4 (Reuters) - U.S. approval for Roche Holding AG's

(ROG.VX: Quote, Profile, Research, Stock Buzz) Actemra has been

delayed further after regulators asked for more non-clinical data on

the potential blockbuster rheumatoid arthritis drug.

The Swiss group said on Thursday the Food and Drug Administration

(FDA) had requested additional animal model data but had not ordered

further clinical studies, and that the company would submit the

required information in the third quarter of next year.

*****************************************************

Read the entire article here:

http://www.reuters.com/article/euIpoNews/idUSL446342220081204

Not an MD

[Guest guest]

Kami,

I haven't seen those numbers, but it would be important to know how

many people participated in the studies and how many deaths would have

been expected in a typical RA population, too.

Not an MD

On Sun, Dec 7, 2008 at 12:27 PM, ~ Kami ~ <kamilleon@...> wrote:

> My doctor was telling me that when they unblinded the study, there were 11

> deaths related to (if I remember correctly) cardiovascular in patients who

> actually received the drug and not placebo.

>

> He also told me that they did clinical trials at his office with great

> results for this medication........

>

> w] ~]ss Kami ss] ~]w