RE: Traumakine23 Mar 2020 13:52
The Traumakine drug from Turku-based drug development company Faron Pharmaceuticals is wanted as the last resort in the intensive care of coronavirus patients. The address, created on Thursday, has been signed by about 250 people by Friday night.
The address requires Fimea , the National Agency for Safety and Development, to authorize the use of the medicine as soon as possible to treat serious cases with the patient's consent.
- This drug has the potential to save hundreds, if not thousands of lives in Finland, justifying the address.
Traumakine is developed for the treatment of respiratory failure syndrome, ARDS. The medicine has not been authorized by Fimea.
The problem was the Phase 3 study in 2018, which did not produce the desired results. There was no statistical difference in mortality in patients treated with Traumakine or placebo.
According to Fimea, positive results from a new study would be needed to demonstrate the efficacy and safety of the product.
- The public statement that 'the drug has no side effects' is also incorrect. All medicines have side effects. Traumatic efficacy and safety in the treatment of acute ARDS should be demonstrated in a randomized controlled trial - not yet conducted. Thus, it is clearly premature to say that the medicinal product is "unauthorized", the Fimea website states.