(Boursier.com) – The National Medicines Safety Agency (ANSM) has granted a Compassionate Access Authorization (AAC) for bio-HDL (CER-001) in COVID-19 to next-generation biotech Abionyx Pharma.
COVID-19 is associated with respiratory symptoms characterized by acute lung injury, and rapidly progressing to acute respiratory distress syndrome. Lung dysfunction is quickly accompanied by a large “cytokine storm” in which inflammatory cytokines are liberally released into the blood, causing tissue damage in the host. Decreases in total cholesterol, LDL and HDL levels have been observed in patients with COVID-19 infections. Patients with low HDL on admission to hospital had an increased risk of developing severe disease compared to patients with high HDL. As COVID-19 infections heal, serum lipid levels return to levels present before infection. These lipid abnormalities could be modified by pharmacological agents which increase the plasma levels of ApoA-I and HDL, but above all which increase the functional HDL particles.
Thus, CER-001, a recombinant bio-HDL, could be likely to improve the clinical outcome of patients with COVID-19. Current data do not allow us to assume a favorable risk-benefit ratio for the use of CER-001 within the framework of this authorization.
It should be remembered that in France, the use of pharmaceutical specialties that do not yet benefit from a marketing authorization (MA) and are not the subject of a clinical trial, is subject to prior obtaining from the ANSM of a Compassionate Access Authorization (AAC). Nominative Temporary Use Authorizations (ATUn) become compassionate access authorizations (AAC); the terms and criteria of access to these treatments are not generally modified by the reform for patients or health professionals; manufacturers, on the other hand, must commit to a request for early access if they are considering clinical and commercial development in a given indication.
A compassionate access authorization (AAC) is notably issued by the ANSM under the following conditions:
– the specialties are intended to treat, prevent or diagnose serious or rare diseases,
– there is no appropriate treatment available,
– the authorization is issued at the request and under the sole responsibility of the prescribing physician, when the drug is likely to be of benefit to the patient.
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