A Conditional Application for a New Vasculitis Treatment Was Just Accepted By The EMA

According to a story from ANCA Vasculitis News, The European Medicines Agency just approved the pharmaceutical company ChemoCentryx’s application for the marketing of avacopan as a potential treatment for anti-neutrophil cytoplasmic antibody (ANCA) related vasculitis.
Vasculitis is a condition in which inflammation destroys the blood vessels. Vasculitis affects veins and arteries. The condition is caused by the migration of leukocytes. The symptoms can vary greatly, as vasculitis is classified by the underlying cause, location, and the blood vessels that are affected. Symptoms include weight loss, fevers, abdominal pain, nose bleeds, heart attack, headache, stroke, vision loss, and arthritis. ANCA associated vasculitis is often systemic and has severe symptoms. Treatment is focused on stopping the inflammation response and suppressing the immune system. To learn more about this condition, click here.

ChemoCentryx had applied for an authorization for marketing the avacopan treatment. Although conditional, it is possible for the company to begin marketing because the drug is treating a serious, life-threatening condition that has very limited treatment options currently. The drug will still have to undergo that standard regimen of clinical trials and testing, however.

Avacopan is a highly targeted immune system suppressor that halts the function of an immune receptor called C5aR. This receptor plays a role in ANCA vasculitis and the targeted treatment means that other immune system processes would not be inhibited in any way, which offers a significant advantage over other currently available immune system suppressors. A phase 3 trial studying the treatment is still in the recruitment stage, but previous trials have demonstrated that the treatment has significant potential. They also confirmed the role of C5aR in the development of vasculitis.

Current treatment options are also linked to severe side effects that can include potentially fatal infections as the result of using immune suppressors that are less targeted. Avacopan was also listed for Priority Medicine status with the EMA. This status allows for a more efficient and fast paced regulatory review process for the drug. If the drug successfully reaches full approval, it has the potential to revolutionize the way that vasculitis is treated and will hopefully provide superior outcomes to patients.


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