Oct 4 (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)
Astrazeneca (AZN)
Glaxosmithkline (GSK)
