Tysabri and fertility

[RuSmolikova]

You know that I am not comfortable with any comments that come from Biogen employees when it comes to information on Tysabri. We all know their track record.

Fortunately FDA does not sleep...
http://www.fiercepharma.com/story/fda-w ... 2010-04-08

I guess ... there really isn't a definitive answer ... it is safe to use Tysabri and become pregnant.

It is a million dollar question!

[HarryZ]

Fortunately FDA does not sleep...
http://www.fiercepharma.com/story/fda-w ... 2010-04-08

I read the actual letter of warning that you posted a few weeks ago. I think the FDA used the word "misleading" six times in how Biogen minimized PML risk in their webcast.

I'm not surprised at Biogen's actions. They have a record of doing promotions like this with Tysabri. Although this drug has brought in over $ 1 billion of revenue so far, that number is far below what Biogen/Elan had hoped for in their marketing. A few misleading comments in a webcast doesn't appear to be a problem for them!

Harry

[RuSmolikova]

They still have more than 7 months to reach their main goal: 100.000 MS patients on Tysabri at the end of 2010.
(today it is about 50.000...)

[HarryZ]

They still have more than 7 months to reach their main goal: 100.000 MS patients on Tysabri at the end of 2010.
(today it is about 50.000...)

Their original marketing plan, which was actually outlined on the net prior to Tysabri being originally approved, showed a market share of 85% for MS meds and a lot more than 100,000 patients. With PML showing up, they have obviously had to re-think those numbers.

As well, as each month passes, other problems such as infections etc, are starting to surface and that has many MS docs concerned for their patients.

Harry

[RuSmolikova]

...As well, as each month passes, other problems such as infections etc, are starting to surface...Harry

Yeh, yeh.
I will not mention already known incidence of melanoma or severe damage of liver. But this information was new for me:
http://www.ncbi.nlm.nih.gov/pubmed/20454819

[chilli123]

ARTICLE:
Delivery of healthy babies after natalizumab use for multiple sclerosis: a
report of two cases
Acta Neurologica Scandinavica
I. A. Hoevenaren L. C. de Vries R. J. P. Rijnders F. K. Lotgering
DOI: 10.1111/j.1600-0404.2010.01426.x

http://onlinelibrary.wiley.com/doi/10.1 ... x/abstract

[HarryZ]

ARTICLE:
Delivery of healthy babies after natalizumab use for multiple sclerosis: a
report of two cases
Acta Neurologica Scandinavica
I. A. Hoevenaren L. C. de Vries R. J. P. Rijnders F. K. Lotgering
DOI: 10.1111/j.1600-0404.2010.01426.x

http://onlinelibrary.wiley.com/doi/10.1 ... x/abstract

Would you base your decision on the bases of two cases? Like the article said, they can't determine one way or the other if Tysabri is safe for pregnant women.

Harry