AstraZeneca's Lynparza Approved in EU for Ovarian Cancer - Analyst Blog

Zacks Equity Research
Updated

The European Commission (EC) approved AstraZeneca’s (AZN) Lynparza as a monotherapy for the maintenance treatment of adults suffering from platinum sensitive relapsed BRCA-mutated high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

The approval of Lynparza in the EU does not come as a surprise as the Committee for Medicinal Products for Human Use gave a positive opinion on the approval of the drug in Oct 2014. Lynparza is the first PARP inhibitor to be approved in the European market for the treatment of platinum sensitive relapsed BRCA-mutated high grade serous ovarian cancer.

Our Take

We are encouraged by the approval of Lynparza. The product’s fate was however not that good in the U.S. In Jun 2014, AstraZeneca announced that the FDA’s Oncologic Drugs Advisory Committee voted against the approval of this oncology candidate (read more: AstraZeneca's Olaparib Fails to Impress FDA Panel).

We note that Clovis Oncology’s (CLVS) rucaparib is another PARP inhibitor being developed for the treatment of platinum-sensitive ovarian cancer patients.

AstraZeneca received several regulatory approvals like Duaklir Genuair (chronic obstructive pulmonary disease) and Moventig (opioid-induced constipation), over the last few months. We note that AstraZeneca is under severe pressure as it is facing generic competition in several key franchises.

Moreover, another key product, Nexium, which generated more than 15% of AstraZeneca’s total revenues last year, is expected to go generic soon. The company’s pipeline needs to deliver significantly to offset these losses.

AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Allergan (AGN) and AbbVie Inc. (ABBV). Both stocks hold a Zacks Rank #2 (Buy).


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
 
ALLERGAN INC (AGN): Free Stock Analysis Report
 
ABBVIE INC (ABBV): Free Stock Analysis Report
 
CLOVIS ONCOLOGY (CLVS): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research