AstraZeneca’s Fasenra set to be approved for eosinophilic granulomatosis treatment
Fasenra represents a much-needed potential treatment option for patients struggling with eosinophilic granulomatosis with polyangitis (EGPA) to help them achieve remission and taper off steroid therapy
- byAPR Team
- 23 Sep, 2024
- 1 Mins
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Fasenra, whose active pharmaceutical ingredient is benralizumab, has been recommended by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, as an “add-on” therapy for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA).
The committee’s decision was based on clinical trial data published in The New England Journal of Medicine, which showed that Fasenra demonstrated comparable remission rates compared to mepolizumab, the only approved EGPA treatment.
According to the Phase III study with the code MANDARA, 60% of patients treated with Fasenra experienced remission.
A rate comparable to the mepolizumab-treated patients.
EGPA is a rare immune-mediated inflammatory condition caused by inflammation of small to medium-sized blood vessels. It is characterized by severe exhaustion, loss of weight, rashes, muscular and joint discomfort, nerve pain, symptoms related to the sinuses and nasal passages, and dyspnea. The condition may lead to damage to the heart, gastrointestinal tract, skin, lungs, upper airways, and nerves, among other organs.
The study was a randomized 1:1, double-blinded active-controlled trial involving 140 participants. With a group receiving either a single 30 mg subcutaneous injection of Fasenra or three separate 100 mg subcutaneous injections of mepolizumab every four weeks.
In a key secondary endpoint, the trial found that 41% of patients treated with Fasenra fully tapered off oral corticosteroids compared to 26% in the comparator group.
“With its unique mechanism of action that leads to near complete depletion of eosinophils, Fasenra represents a much-needed potential treatment option for EGPA patients to help them achieve remission and taper off steroid therapy,” Bernhard Hellmich, MANDARA Principal Investigator.
According to AstraZeneca, the safety and tolerability profile for Fasenra in the MANDARA trial was consistent with the known profile of the medicine.
“With over 15 years of clinical data, Fasenra is a well-established, leading treatment for severe eosinophilic asthma and now has the potential to transform care for patients with EGPA. Today’s news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma," said Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca.
At the moment, over 80 nations, including the US, EU, China, and Japan, have approved Fasenra for severe eosinophilic asthma as an add-on maintenance therapy.
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APR Team
African Pharmaceutical Review team dedicated to providing the latest news, insights and developments from the pharma, biotech and medtech industries.