Helsinn And AB Science Persevere In EU Despite CHMP Setback

Helsinn and AB Science plan to conduct additional studies with their products the CHMP turned down this month, in an effort to secure eventual EU approval in the rejected indications. A third company, XBiotech, hasn’t ruled out similar action. New MAAs would be required.

Upward arrows to success
Helsinn, AB Science and XBiotech are consdering their next moves • Source: Shutterstock

Helsinn and AB Science are ploughing ahead with the development of products in the indications that got a resounding vote of no confidence from the European Medicines Agency earlier this month in the hope of securing future EU approval. XBiotech, which also received bad news, has not ruled out submitting a new marketing authorization application for its product in the indication that has just been rejected.

Helsinn Birex Pharmaceuticals Ltd. said it was in discussions with the EMA on “next steps” for an additional Phase...

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