AstraZeneca: Tezepelumab Gets FDA Orphan Designation for Eosinophilic Esophagitis
October 08 2021 - 7:52AM
Dow Jones News
By Colin Kellaher
AstraZeneca PLC on Friday said the U.S. Food and Drug
Administration granted orphan-drug designation to tezepelumab for
the treatment of the rare inflammatory disease eosinophilic
esophagitis.
The U.K. pharmaceutical giant, which is developing tezepelumab
with Amgen Inc., said there are currently no approved treatments in
the U.S. for eosinophilic esophagitis, which can make eating
difficult or uncomfortable, potentially leading to chronic pain,
difficulty swallowing, poor growth, malnutrition and weight
loss.
The FDA's orphan-drug program gives special status to drugs and
biologics for diseases and disorders that affect fewer than 200,000
people in the U.S. and provides for an extended
marketing-exclusivity period against competition.
AstraZeneca and Amgen, a Thousand Oaks, Calif., biotechnology
company, agreed in 2012 to collaborate on tezepelumab, which is
currently under FDA priority review for patients with asthma, with
a decision expected early next year.
Under an update earlier this year to their collaboration, Amgen
and AstraZeneca will continue to share costs and profits equally
after payment by AstraZeneca of a mid-single-digit royalty to
Amgen. AstraZeneca continues to lead development of the drug, while
Amgen leads manufacturing.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
October 08, 2021 07:37 ET (11:37 GMT)
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