Daewoong Pharmaceutical's advancement into Europe with its botulinum toxin Nabota (European name: Nuceiva) has been delayed.
According to the bio industry on June 11, the Daewoong Pharmaceutical's U.S.-based partner, Evolus, said in a press release on June 10 that it had been asked by the European Commission to submit supplementary data on Nuceiva and that the final decision on the item's permit could be delayed from the previous schedule.
Earlier in April, Evolus and Daewoong Pharmaceutical obtained recommendations from the CHMP of the European Medicines Agency (EMA) on the European licensing of Nuceiva on its effects of improving fine wrinkles.
CHMP is an organization that evaluates effectiveness and safety of medicines and presents opinions on licensing to EC. Normally, the CHMP's recommendation for approval of an item's license will be finalized within 90 days of the recommendation.
However, the final approval decision will be over 90 days as the EC requested supplementary data to review the Nuceiva permit application.
In response, Daewoong Pharmaceutical said, "EC had requested additional documents. Accordingly, the approval schedule may be delayed, but it does not directly affect the approval."
