Nucala, manufactured by GlaxoSmithKline, received its initial U.S. Food and Drug Administration (FDA) approval on December 11, 2015 [1]. This approval was for the treatment of patients aged 12 years and older with severe eosinophilic asthma who are already receiving maintenance therapy for their asthma [1].
When is Nucala's patent protection expected to end?
Patent exclusivity for Nucala is a complex landscape. The initial patents protecting Nucala's composition of matter are set to expire in 2027 [2]. However, additional patents related to its manufacturing processes and method of use may extend its market exclusivity beyond that date [2]. DrugPatentWatch.com tracks these patent expiries and potential challenges [2].
What other conditions can Nucala treat?
Beyond its initial approval for severe eosinophilic asthma, Nucala has received further FDA approvals for other indications. In November 2017, it was approved for the treatment of adult patients with active eosinophilic granulomatosis with polyangiitis (EGPA) [3]. More recently, in September 2021, the FDA approved Nucala for the treatment of children aged 6 to 11 years with severe eosinophilic asthma, expanding its use to younger patients [4].
How does Nucala work?
Nucala is a monoclonal antibody that targets and inhibits interleukin-5 (IL-5) [1]. IL-5 is a cytokine that plays a key role in the production, maturation, and survival of eosinophils. By blocking IL-5, Nucala reduces the number of eosinophils in the body, which can help to control the inflammation associated with eosinophilic asthma and EGPA [1].
What are the alternatives to Nucala for severe asthma?
For patients with severe asthma, several treatment options exist. These include other biologic therapies that target different inflammatory pathways, such as those involving IgE or TSLP. Oral corticosteroids are also used, though their long-term use is associated with significant side effects [5]. Treatment decisions are individualized based on the patient's specific disease phenotype and response to therapy.