AstraZeneca’s Fasenra for Rare Diseases Granted Approval by EU

AstraZeneca’s Fasenra for Rare Diseases Granted Approval by EU

AstraZeneca’s Fasenra for Rare Diseases Granted Approval by EU

The European Commission has officially approved Fasenra (benralizumab) as an adjunct therapy for adult individuals suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). This decision follows a favorable recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) just a month earlier.

As a rare ailment characterized by inflammation of small blood vessels, EGPA leads to restricted blood circulation and potential damage to various organs, and it can be life-threatening if not addressed. It is estimated that nearly 47% of patients are unable to achieve remission with the treatment options currently available, which often necessitate the use of elevated doses of oral corticosteroids.

In the MANDARA phase 3 clinical trial, Fasenra’s effectiveness was contrasted with mepolizumab, a monoclonal antibody that has also received approval for treating EGPA. The study involved 140 participants who were randomly assigned to receive either a single dose of Fasenra or three doses of mepolizumab, administered at four-week intervals.

Results indicated that close to 60% of patients given Fasenra reached remission, a statistic on par with the outcomes seen with mepolizumab. Moreover, 41% of those treated with Fasenra were able to completely taper off corticosteroids, compared to only 26% of those receiving mepolizumab.

“Patients with EGPA experience debilitating symptoms and may face severe organ damage or even death. This new approval represents a crucial treatment option for individuals managing EGPA in the EU. Targeting and eliminating eosinophilic inflammation through benralizumab may lead to higher remission rates and lessen the dependency on oral corticosteroids, known for their serious and lasting side effects,” commented Bernhard Hellmich, Chair of the Department at Medius Klinik Kirchheim and Principal Investigator for the MANDARA clinical trial.

The recent EU approval for Fasenra comes closely on the heels of its approval in the United States in September. Additionally, the antibody medication is sanctioned in over 80 countries as a supplementary maintenance treatment for severe eosinophilic asthma (SEA), which typically impacts around half of those diagnosed with EGPA.

“The approval of Fasenra, which allows for a convenient monthly injection, marks a significant advancement for patients dealing with EGPA. Fasenra has been a proven therapy for numerous patients suffering from severe eosinophilic asthma for years, and we are excited to extend this crucial treatment option to those with EGPA in Europe,” remarked Ruud Dobber, Executive Vice President of the Biopharmaceuticals Business Unit at AstraZeneca.