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Drug approval USA Germany
- Question
- Dear expert team,
There are promising new medicaments for the treatment of Cystic Fibrosis in the drug development pipeline, among these, substances of Vertex. Just in case these drugs will be approved, how likely is it in your opinion that these Vertex substances (and others like Denufosol and Moli) will be approved in the US earlier than in Germany?
Greetings and thank you for your efforts.
- Answer
- Dear Sir or Madam,
Thank you for your important question. Since the development and hitherto existing results of the new substances are promising to improve the treatment significantly, it is understandable that the date of availability is particularly relevant for CF persons and care team members.
Generally speaking , the companies which are developing the substances are highly interested in getting the marketing authorisation for the medicaments as soon as possible for the USA, Australia and Europe (which includes Germany). However, since the authorisation is done by different authorities (e.g. in the US the “Food and Drug Administration” / FDA, in Germany the “European Medicines Agency” / EMEA and the so called “Bundesinstitut für
Arzneimittel und Medizinprodukte“ / BfArM), it can happen that the medicament is approved earlier in one part of the world than in another. But this does not mean that the medicaments are always approved at first in the US. It also could be vice versa.
A person who participates – before approval – in the development or rather test of a new medicament within the framework of a so called phase III study, usually gets the medicament not only during the study itself (at least for a certain period) but can also receive the medicament (if there are no security worries) after the study until it is approved.
Therefore, it is worth thinking about the participation in such a study not only for the community of CF patients but also for the individual.
[In the original German question there was a link to the German patient organisation which offers information for those who are interested in participating in a study.]
Best regards,
Helge Hebestreit
- 05.11.2009
