Fasenra

AstraZeneca took the opportunity at the American Thoracic Society 2020 Virtual International Conference to unveil positive new Phase 3b data on the efficacy of Fasenra (benralizumab) in the treatment of severe eosinophilic asthma.

The company revealed that the therapy, in combination with standard of care, generated a reduction of 49% in the annual rate of asthma exacerbations 24 weeks after initial dosing compared to placebo in patients with baseline blood eosinophil counts of at least 150 cells per microlitre.

AstraZeneca is celebrating as the FDA announced the approval of its IL-5 inhibitor Fasenra  (benralizumab) in a pre-filled, single-use auto-injector form, known as the Fasenra Pen.

The decision was based on Phase 1 and 3 data from two separate trials, and follows the product’s approval in the EU. Fasenra is currently approved in the US, EU, and Japan as an add-on treatment for eosinophilic asthma.

AstraZeneca has revealed new data for Fasenra (benralizumab), demonstrating that patients using the drug can “achieve near-complete depletion of eosinophils and improve clinical outcomes” in hypereosinophilic syndrome (HES)

In a Phase 2 trial of 20 participants, 90% achieved the primary endpoint of an at least 50% reduction in their absolute blood eosinophil counts after 12 weeks of treatment, compared to 30% with placebo.  

It’s good news for both asthma patients and AstraZeneca after UK drug watchdog NICE saw fit to recommend the drugmaker’s Fasenra (benralizumab) injection as a new option on the NHS in England and Wales for those living with severe forms of the disease.

The decision means that Fasenra becomes the third biological treatment available on routine use for the treatment of severe eosinophilic asthma, alongside GlaxoSmithKline’s Nucala (mepolizumab), recommended in December 2016, and Teva’s Cinqaero (reslizumab), recommended in October 2017.

It looked unlikely that Fasenra would achieve success in the chronic obstructive pulmonary disease (COPD) area, after it suffered in trial results released earlier this month.

AstraZeneca has now released the results from the second trial into the area and they only confirm the company’s fears, the treatment is a dud for COPD.

The short press release simply states that the trial did not meet its primary endpoint of reducing exacerbations and, perhaps coming as no surprise, would not be pursuing a regulatory submission any time soon.

AstraZeneca’s Fasenra arrived later on the scene than GSK rival med, Nucala, and so it needed to quickly rack up indications to mount a serious challenge – in COPD, at least, that looks more unlikely after the treatment wasn’t able to meet its primary endpoints in a Phase 3 trial.

Fasenra is already approved to treat severe eosinophilic asthma in major markets around the world but was hoping to add to this with an expansion into treating exacerbations in those with moderate to very severe COPD.

AstraZeneca has unveiled a double dose of approvals awarded to its medicines in Japan: Fasenra (benralizumab) has been given authorisation as an add-on treatment for severe asthma sufferers, while Lynparza (olaparib) has been given the go-ahead as a maintenance therapy in patients with ovarian cancer who responded to chemotherapy, regardless of BRCA mutation status.

AstraZeneca and its biologics R&D unit MedImmune have announced that their drug Fasenra (benralizumab) has received approval from the European Commission (EC) as an adjuvant therapy in the treatment of severe eosinophilic asthma which has been inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.

AstraZeneca and MedImmune, the company’s biologics research and development division, have revealed the decision by the FDA to approve Fasenra (benralizumab) in the US as an add-on treatment for severe asthma in patients over 12 with an eosinophilic phenotype.