AstraZeneca’s Breast Cancer Drug Exclusivity in the U.S. Prolonged by Six Months

GEN News Highlights

FDA extended the exclusivity time period for breast malignant neoplastic disease drug Arimidex® by granting a six-month paediatric exclusivity. Yet, the house states that it will not prosecute blessing of the drug for usage in children.

AstraZeneca will go on to marketplace Arimidex in postmenopausal women until June 2010. The patent of invention was previously owed to run out in December 2009.

“Preclinical and clinical information supported the probe of the curative potentiality of Arimidex in paediatric statuses that apparent symptoms resulting from increased oestrogen production, for illustration gynecomastia in pubertal male children and precocious pubescence in misses with McCune-Albright Syndrome,” states Toilet Patterson, executive manager director of development.

Based on the trial results, however, Dr. Patterson short letters that the company will not seek a blessing in either condition. The surveys reportedly did not demo a positive affect compared with placebo in gynecomastia nor did they happen a benefit in treating early puberty.

Arimidex reportedly have a 38.3% share of entire prescriptions for hormonal treatments for breast cancer. In the U.S., AstraZeneca reported that gross sales reached $507 million for the nine calendar months of 2007, up 15% from the same time period of 2006.

In 1995, Arimidex was first sanctioned as a therapy for advanced breast malignant neoplastic disease in postmenopausal women with disease patterned advance followers tamoxifen. About five old age later, AstraZeneca expanded the label to include first-line treatment of postmenopausal women with internal secretion receptor positive or internal secretion receptor unknown region locally advanced or metastatic breast cancer. The up-to-the-minute indicant for the drug came in 2002, when the federal agency approved Arimidex as an adjuvant treatment of postmenopausal women with internal secretion receptor positive early breast cancer.