FDA has given a surprise approval for Lynparza, the pharmaceutical giant’s new drug for ovarian cancer.
Shares made a brief correction from the downward slope that AstraZeneca have experienced since mid-November, up across the last week from 4390 to 4583.
The FDA, U.S. Food and Drug Administration, announced the approval through a press release: “The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test. “Today’s approval constitutes the first of a new class of drugs for treating ovarian cancer,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Lynparza is approved for patients with specific abnormalities in the BRCA gene and is an example of how a greater understanding of the underlying mechanisms of disease can lead to targeted, more personalized treatment.”
AstraZeneca reported, “The FDA is approving Lynparza under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts confirmatory clinical trials.
The FDA’s approval follows the announcement on 18 December of the approval of olaparib in the European Union, as the first therapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer.”
In November, AstraZeneca issued Q3 results with positive growth figures of a third consecutive quarter of revenue growth; $6.5 billion, +5%, and growth platforms up +16% YTD, contributing 54% of total revenue. China and Japan were cited as the largest growth markets for hospital sales and underlying demand.
After a whirlwind romance with US based Pfizer, AstraZeneca rejected the sweetened deal of $118 billion back in May 2014. Pfizer wanted to join with the British firm to shift their tax base to the UK. Since then, AstraZeneca have corroborated their independent stance by gaining FDA approval on Lynparza, a drug that has the potential to reach $2 billion worth of annual sales.
In the meantime, The UK100 [FTSE], where AstraZeneca trades on MT4, made large gains last week, up 500 points from 6070 to 6570.
MT4 chart: AstraZeneca
MT4 chart: UK100
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