Daewoong Pharmaceutical is expected to face a delay in obtaining European approval for botulinum toxin Nabota (European product name: Nuceiva), beyond the planned schedule of late July.
Evolus, Daewoong’s partner firm proceeding with Nuceiva license in Europe, received a request from the European Commission (EC) to submit additional data regarding marketing authorization applications (MAA) for Nuceiva, according to sources in the biotech industry.
“The final decision whether to approve could take longer than expected,” a source said.
On April 26, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for granting the nod for Nabota. CHMP is a consultative body, evaluating a drug’s efficacy and safety and suggesting an opinion to the European Commission.
Usually, after a CHMP’s recommendation for approval, it takes about 90 days for the EC to make the final decision. Industry watchers had expected that Nabota would win the license in late July.
However, as the EC demanded additional information, the EC’s decision-making process could be extended beyond late July.
Evolus and Daewoong said they had no problem to release Nabota in the European market.
“The CHMP conducted a thorough review before granting us a positive opinion,” said Rui Avelar, chief medical officer and head of research and development at Evolus. “We will confirm our timeline for approval upon receipt of clarification from the European Commission.”
An official at Daewoong also said, “The data requested by the EC is not something to influence approval. The approval proceedings could be delayed a little bit, but there will be no issue to obtain the license.”
In May last year, Nabota approval by the U.S. Food and Drug Administration was slightly suspended as the regulator demanded additional data. Evolus submitted the data and won the sales license for Nabota in February. The product is available under the brand name Jeuveau across the U.S.
Once Daewoong receives the green light for Nabota from EC, it can sell the anti-wrinkle injection in 31 countries in Europe. Nabota will become the first Korean botulinum toxin to arrive in Europe after the U.S.
The U.S. and Europe account for over 70 percent of the global botulinum toxin market. Upon the completion of obtaining a license in the U.S. and Europe, Daewoong is to receive about 10 billion won in additional milestone from Evolus.
Evolus, which has the sales rights of Nabota in North America and Europe, is searching for a local partner to prepare the release of Nabota in Europe.