October 4, 2019 / 7:16 AM / 12 days ago

FDA green lights AstraZeneca's asthma drug Fasenra for self-administration

FILE PHOTO: A sign is seen at an AstraZeneca site in Macclesfield, England, May 19, 2014. REUTERS/Phil Noble

(Reuters) - British drugmaker AstraZeneca said on Friday that the U.S. Food and Drug Administration (FDA) has approved self-administration of its asthma treatment Fasenra which uses a pre-filled, single-use auto-injector pen.

The move is a boost for the drugmaker’s respiratory portfolio after the regulator earlier this week declined to approve AstraZeneca’s combination therapy to treat smoker’s lung, as it tries to catch up with domestic rival GlaxoSmithKline.

“We can now offer Fasenra in an even more convenient way, giving U.S. healthcare providers and patients the option of administering Fasenra at home or in a doctor’s office,” Mene Pangalos, executive vice president of BioPharmaceuticals R&D said.

Fasenra self-administration and the Fasenra Pen are already approved in the European Union and the drug is part of AstraZeneca’s newer class of medicines, which it is banking on to sustain sales growth.

The FDA in August granted expedited approval for the drug, speeding up its development to treat eosinophilic oesophagitis, an allergic inflammation of the esophagus that involves a form of white blood cells, eosinophils.

Fasenra, AstraZeneca’s first respiratory biologic, had sales of $297 million in 2018 and is approved as an add-on maintenance treatment in severe eosinophilic asthma in the U.S., Europe and Japan.

The drug belongs to a class of medicines called monoclonal antibodies and binds to certain receptors on blood cells and boosts the body’s natural response to induce programmed cell death.

Reporting by Pushkala Aripaka in Bengaluru; Editing by Bernard Orr

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