An Envision study of hepatic hepatic acupuncture treatment has already been known to have shown a significant reduction in life-threatening attacks associated with this disease. Today, EASL has provided experts with the scope of this benefit.
The average annual rate of composite seizures dropped by 74% compared to placebo, which should be imprinted by doctors and allow regulators the comfort of approval. However, three serious security events mean that this is not a dead end.
Nevertheless, each of the 94 people involved decided to move into a long-term prolonged study, suggesting that patients with severe forms of AHP feel that treatment with a givoserene is worth a try.
Another important point to remember is that only 50% of patients were without an attack, compared to 16% in placebo. Dr. Manisha Balwani, the leading researcher of Envision, who presented information to journalists at a conference yesterday, did not want to comment on the responses seen in the other 50% of patients. basis.
This is definitely the issue that regulators will want to answer while security is being examined. Three serious safety events – high fever, kidney disease and elevated liver enzymes – were previously predicted last month, with a hit at the top (Alnylam touts givosiran won despite toxic fears, March 6, 2019).
Theresa Heggie, senior vice president of Europe and Canada Alnylm, stressed that problems with the kidneys and liver may be the burden of this disease, but admitted that it can not exclude the effect of being givos.
»Transitional changes to [signals of kidney disease] save, and that encouraged us. And in these patients we continued to measure liver enzymes that normalized. We believe that the risk-benefit ratio is to a large extent favorable to the living, "she said Vantage at EASL.
Many raise concerns about basic toxicity problems with the RNAi technology platform and will wait with interest to see how the regulators will be regarding these signals.