AstraZeneca Says FDA Rejects Asthma Drug Fasenra For Treatment of Nasal Condition
14 März 2022 - 9:05AM
Dow Jones News
By Anthony O. Goriainoff
AstraZeneca PLC said Monday that the U.S. Food and Drug
Administration has rejected its asthma drug fasenra for the
treatment of chronic rhinosinusitis with nasal polyps, but that
lynparza has been approved for early breast cancer.
The Anglo-Swedish pharmaceutical company said the FDA's complete
response letter requested additional clinical data. The company
said it was working closely with the FDA regarding the next
steps.
Fasenra is currently approved as an add-on maintenance treatment
for severe asthma in the U.S., EU, Japan and other countries.
AstraZeneca also said that lynparza has been approved as
additional treatment for patients with early breast cancer who have
already been treated with chemotherapy either before or after
surgery.
The company said that during the OlympiA Phase 3 trial lynparza
showed a statistically significant and clinically meaningful
improvement in invasive disease-free survival. It added the
treatment reduced the risk of invasive breast cancer recurrences,
second cancers or death, by 42% versus a placebo.
Write to Anthony O. Goriainoff at
anthony.orunagoriainoff@dowjones.com
(END) Dow Jones Newswires
March 14, 2022 03:50 ET (07:50 GMT)
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