Mepolizumab, marketed under the brand name Nucala, was first approved by the U.S. Food and Drug Administration (FDA) on March 5, 2015 [1].
When did Nucala become available in Europe?
In Europe, mepolizumab received its initial marketing authorization from the European Medicines Agency (EMA) on November 10, 2015 [2].
What is mepolizumab used for?
Mepolizumab is a monoclonal antibody used to treat severe eosinophilic asthma [1]. It is also indicated for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis and for patients with hypereosinophilic syndrome [3].
How does mepolizumab work?
Mepolizumab targets and inhibits interleukin-5 (IL-5), a key driver of eosinophilic inflammation. By blocking IL-5, it reduces the number of eosinophils in the body [1][3].
What is the patent status of mepolizumab?
Information on the specific patent expiry dates for mepolizumab can be found on DrugPatentWatch.com [4]. Patent details are crucial for understanding when generic or biosimilar competition might emerge.
How does mepolizumab compare to other eosinophilic asthma treatments?
Other biologic treatments for severe eosinophilic asthma include benralizumab (Fasenra) and reslizumab (Cinqair), which also target the IL-5 pathway [5]. Dupilumab (Dupixent) targets the IL-4/IL-13 pathway and is another option for patients with severe asthma, particularly those with an eosinophilic phenotype [6].
What are the reported side effects of mepolizumab?
Common side effects reported for mepolizumab include headache and reactions at the injection site [1]. Serious side effects can occur, and patients should discuss potential risks with their healthcare providers [1][3].