” To allow patients who cannot participate in a clinical trial access to phage therapy in a safe environment The National Agency for the Safety of Medicines (ANSM) announced in a press release that it will now allow compassionate access to two anti-Staphylococcus aureus (PP1493 and PP1815), for the treatment of serious osteoarthritis and osteoarthritis documented in Staphylococcus aureus.
Germs are viruses that could represent a complementary approach to antibiotic therapy to treat patients in a therapeutic dilemma in the troubling context of antibiotic resistance. In fact, they have the peculiarity of infecting only bacteria and their use for therapeutic purposes depends on the mechanism of bacterial lysis. But, “To date, no drug containing phages has a marketing authorization (AMM) in the European Union or in the United States.”recalls ANSM.
Several institutions, including the Parliamentary Office for the Evaluation of Scientific and Technological Options (OPEXT) in 2021, are calling for the development of the sector in France. Potential interest in phage therapy is the subject of regular academic presentations, for example during a joint five-academic session in 2018.
However, clinical trials must be conducted to prove its efficacy. », confirms the health agency. In this context, the PhagoDAIR I clinical trial, recently authorized by ANSM, should begin soon, and others will complement this research. “Clinical trials and compassionate access authorizations can be conducted, because these phages are now produced and controlled to quality standards equivalent to those required for all experimental drugs.”Agency says.
two antiphages-Staphylococcus aureus PP1493 and PP1815 are indicated in adults and adolescents for the treatment of serious bone and osteoarthritis infections documented in Staphylococcus aureuswhen it comes to biological or functional diagnosis and in the case of therapeutic immobility, by topical application or by injection On site. “The use of phages may be considered under the Compassionate Access Authorization (AAC) for patients who cannot participate in a clinical trial (PhagoDAIR I is the only clinical trial authorized in France to date)”We read the press release.
Validation by a reference center
The use of these phages is reserved for hospital use and is subject to a close monitoring procedure by ANSM through a protocol for therapeutic use and the collection of usage and safety data. Bacteriophages PP1493 and PP1815 should be used together to reduce the risk of resistance.
It is required that “Each prescription request must be validated by a collective opinion provided by a Reference Center for Complex Osteoarthritis (Krewak).”. This will take into account the result of the graph that needs to be done to test the activity of each phage on the bacteria responsible for the infection. Crioacs, made up of multidisciplinary teams specialized in the management of bone and joint infections, are spread throughout the national territory.
#Swallowing #therapy #authorized #compassionate #access #osteoarthritis