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AstraZeneca Withdraws Cediranib Marketing Application in EU

Zacks

AstraZeneca plc AZN announced that the company has decided to withdraw its Marketing Authorisation Application (MAA) for cediranib in the EU because of certain outstanding questions by the regulatory agency remaining at such a late stage in the review process.

The company was looking to get cediranib approved, in combination with platinum-based chemotherapy followed by maintenance monotherapy, for the treatment of adults with platinum-sensitive relapsed ovarian cancer, including the fallopian tube or primary peritoneal sub-types.

The MAA was submitted to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in Jun 2015 based on results from a phase III study (ICON6) conducted by the Medical Research Council Clinical Trials Unit at University College London.

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AstraZeneca, however, stated that its decision to withdraw the application will not affect the ongoing development program on cediranib, in which the candidate is being evaluated as a combination treatment along with the company’s ovarian cancer drug Lynparza.

The company recorded Lynparza sales of $98 million in the first six months of 2016.

Drugs currently approved to treat ovarian cancer include Avastin, Gemzar, and Paraplatin among others.

Tesaro, Inc. TSRO is also looking to get its candidate, niraparib, approved for the treatment of patients with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. The company has initiated a rolling submission of a New Drug Application (NDA) in the U.S. and intends to complete the submission in the fourth quarter of 2016. The MAA for niraparib is also expected to be submitted for EMA review in the fourth quarter.

AstraZenecacurrently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. PCRX and ANI Pharmaceuticals, Inc. ANIP. Both the stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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