EU approves AZ’ biologic Fasenra for severe asthma
AstraZeneca’s biologic Fasenra has been approved for use in Europe as an add-on maintenance treatment in patients with severe eosinophilic asthma.
Specifically, the drug’s label allows for its use in adults inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.
AZ says Fasenra (benralizumab) - a monoclonal antibody that recruits natural killer cells to deplete eosinophils - is the first-ever approved respiratory biologic medicine with an eight-week maintenance dosing schedule.
Approval is based on the results from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III OCS-sparing trial, ZONDA.
Results from SIROCCO and CALIMA showed reductions in the annual rate of asthma exacerbations of up to 51 percent, and an improvement in lung function with a change in FEV1 of up to 159 mL, seen at four weeks after the first benralizumab dose and sustained throughout the treatment period.
Also of note, there was an improvement in asthma symptoms such as wheeze, cough, chest tightness and shortness of breath, and the adverse event frequency was similar between benralizumab-treated patients and those in the placebo arm in both trials.
“Many patients with severe eosinophilic asthma experience debilitating symptoms and face increased risk of emergency room visits, hospitalisations and death, despite current treatments,” said Tim Harrison, professor of Asthma and Respiratory Medicine, University of Nottingham, UK, and investigator in the WINDWARD trial programme.
“I look forward to being able to offer Fasenra as a new anti-eosinophilic monoclonal antibody which has demonstrated efficacy versus placebo in pivotal clinical trials and has the convenience of an 8-week maintenance dosing regimen.”
Benralizumab is in-licensed from BioWa, a wholly-owned subsidiary of Kyowa Hakko Kirin. Under the exclusive license agreement, the firms have exclusive development and commercialisation rights for benralizumab in Japan and certain countries in Asia. AZ has exclusive rights for the drug in all other countries including the US and Europe.
The drug was approved in the US in November for patients aged 12 years and over.
11th January 2018http://www.pharmatimes.com/