Another day, another drug.
What makes the FDA’s approval of Novartis AG’s (NVSEF) interferon beta-1b (Extavia) important?
Critics may argue that Extavia is exactly the same drug as Bayer’s Betaseron, but this is still a significant step towards further MS treatment development for two reasons:
1. Novartis has been waiting for this approval for some time – it is already available in Europe. There were rumors that the delay was because the FDA was hesitant to open the road to bio-similars (and hence the lack of approval of EMD Serono’s Rebif New Formulation (RNF) [an affiliate of Merck KGaA]). The issue here is that Extavia is 2006 Betaseron – not similar but exact.
2. This is also clear indication that Novartis is staying in the MS market and that (hopefully) FTY720 (Fingolimod) will make it through the approval process (as the second, but thus far, strongest, oral medication for MS disease modification.
This will also be a boost to MS patients as greater competition may lead to lower prices – but even if it doesn’t, Extavia will return us to Betaseron, circa 2006. This means that there will be 15 injections per box and that the injections will be used with the old autoinjector.
Fifteen injections in a box means 12 boxes a year and not 13, this makes more sense intuitively from an every other day point-of-view and means that patients (and insurances) are paying for 12 copays a year, as opposed to 13. Also, many patients prefer the older autoinjector for several reasons:
1. The grip is thinner.
2. Less pressure is needed when holding the injector to the skin (and thus less likely for the needle to go into the muscle).
3. The injection takes less time.
So, what does this all mean?
We will see, but in the meantime -- Welcome Novartis to the MS community!
--
Extavia was approved on 08/14/09 and will be available starting 10/10/09, with a lauch planned for September 2009.
- Dr. Daniel Kantor, MD BSE
Medical Director
Neurologique
info@neurologique.org
www.neurologique.org
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