Sedana Medical has submitted an application seeking approval for its drug candidate Sedaconda (isoflurane), previously called IsoConDa, for inhaled sedation in intensive care.
The application has been filed with the German Medicines Agency BfArM and various other European Medicines Agencies via the DCP procedure.
The market approval application is based on the results of the company’s phase 3 study – SED-001.
As per its findings, the study achieved its primary goal, which is to demonstrate that Sedaconda administered with AnaConDa is an effective sedation method, for ventilator-intensive care patients, and is non-inferior to propofol.
The results proved that Sedaconda is an effective and safe sedation method, said Sedana Medical.
According to the Swedish medical technology company, the application is the starting point of the review process of Sedaconda in 15 of the member states in the European Union, including Norway.
Sedana Medical said that if everything goes well, it anticipates approval in the second half of next year. Following that, the company can submit an application for the second group of European countries.
Usually, it takes nearly six months to get approval for the second group of countries, said the company.
Christer Ahlberg – CEO of Sedana Medical said: “When we get market approval for Sedaconda, we can exclusively launch the treatment inhaled sedation in Europe.
“The treatment consists of our drug Sedaconda, which is then approved for administration only via our medical device AnaConDa. We have chosen the name Sedaconda to strengthen the connection to Sedana Medical and to the drug’s unique area of use, sedation.
“At the same time, we want to communicate that the drug will be given via AnaConDa by keeping CONDA in the name.”
Sedana Medical will separately submit an application for Sedaconda in the UK in Q1 2021. In Switzerland as well, the company plans to submit an application next year.