#Food and Drug Administration#stand-alone biologic drug appl

Sanofi, Regeneron Pharma win US nod for Zaltrap

Sanofi and Regeneron Pharmaceuticals Inc have secured the U.S. nod for Zaltrap to treat patients with advanced colorectal cancer who have not been help...

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|Aug 6|magazine6 min read

Sanofi and Regeneron Pharmaceuticals Inc have secured the U.S. nod for Zaltrap to treat patients with advanced colorectal cancer who have not been helped by earlier therapy, the news reports said.

The Food and Drug Administration has granted its nod for the drug for use in combination with chemotherapy as a so-called second-line treatment for patients whose colorectal cancer has spread to other parts of the body, the agency said.

Regeneron Pharmaceuticals also sells a medicine with the same active ingredient aflibercept under the name Eylea to treat wet age-related macular degeneration, a condition that causes loss of vision.

Food and Drug Administration has granted Zaltrap a new molecular entity status which is reserved for the drugs considered new and innovative chemical structures which previously have not been used in the clinical practice.

Stephanie Yao, FDA spokeswoman said, “FDA grants each stand-alone biologic drug application new molecular entity status.”  

Sanofi Chief Executive Officer Chris Viehbacher reorganized the Paris-based company’s oncology business into a complete division after taking over in December 2008.

The cancer-drug unit also suffered a blow after its most-promising treatment iniparib failed in the study.  As a second-line treatment, Zaltrap may generate peak annual sales of about 300 million euros by 2018, said Corby, who has a buy recommendation for shares of Sanofi. 

Meanwhile, Regeneron is designed to control cancer growth by blocking the supply of blood to the tumor.

According to the National Cancer Institute, more than 143,000 new cases of colorectal cancer are likely to be diagnosed in the U.S. this year.

Zaltrap will also include a boxed warning that can cause severe and sometimes fatal bleeding, including the gastrointestinal bleeding and development of holes in the gastrointestinal tract, FDA said.

Sanofi S.A. is a French multinational pharmaceutical company based in France. The company is involved in the R&D, manufacturing and marketing of pharmaceutical products for sale in the prescription market.

Regeneron is a biotechnology company based in New York. It originally focused on neurotrophic factors and their regenerative capabilities. It branched out into the study of both cytokine and tyrosine kinase receptors.