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 The U.S. Food and Drug Administration's (FDA) decision to endorse
benralizumab, which will be marketed under the name Fasenra, follows
a positive recommendation for the product in Europe on Friday.
Shares in AstraZeneca were 1 percent higher on Wednesday following
the overnight news.
Fasenra will compete with GlaxoSmithKline's Nucala and Teva's
Cinqair - two other injectable antibody drugs for severe asthma -
but AstraZeneca believes its product's potency and convenient dosing
could give it an edge.
The Anglo-Swedish company is also being competitive on cost, setting
a long-term price below that of rivals at $28,000, or $33,000 in a
maintenance year, depending on whether patients receive six or seven
doses.
Treatment in the first year will cost $38,000, as more doses are
needed, which AstraZeneca said was in line with competing biologic
drugs in severe asthma.
While most investor focus is on AstraZeneca's cancer research, the
company also has a long history in respiratory therapy that it plans
to build on with Fasenra and another earlier-stage medicine called
tezepelumab that is developing with Amgen.
Modern biotech asthma drugs are offering new hope for severe asthma
sufferers who continue to have breathing problems despite using
modern inhalers. In the case of Fasrena, the number of severe asthma
attacks was roughly halved in clinical tests.
Fasrena is designed for patients with a particular kind of asthma
driven by a type of white blood cells called eosinophils.
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AstraZeneca had previously said it hoped to win U.S. approval for
the new drug before the end of the year. The FDA approval, announced
late on Tuesday, clears Fasenra as an add-on treatment for severe
asthma patients aged 12 years and older.
"This is the first approval from our respiratory biologics portfolio
and the latest in a series of significant milestones for our company
as we deliver on our pipeline-driven transformation," said
AstraZeneca Chief Executive Pascal Soriot.
Last week, while presenting quarterly results, Soriot said the
drugmaker was moving into a commercial execution mode, following the
success of a number of new medicines in clinical development.
In cancer, it has seen good results in 2017 with two new pills
already on the market - Lynparza and Tagrisso - while its blood
cancer drug Calquence won U.S. approval last month. Imfinzi, its
closely watched immunotherapy medicine, failed in initial tests in
one lung cancer setting but proved successful in another.
(Editing by Louise Heavens)
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