Market Overview

FDA Accepts NDA for Pfizer, Ligand's Bazedoxifene/Conjugated Estrogens

Share:
Related PFE
Benzinga's Top Initiations
The Market In 5 Minutes: Payrolls, Smith & Wesson Earnings And Starbucks' CEO Change
Guggenheim neutral on Pfizer (Seeking Alpha)
Related LGND
18 Biggest Mid-Day Gainers For Wednesday
Retrophin Up 40% On Kidney Disease Drug Trial, Shkreli Still Wants His $25+ Million 'Hogan Reward'

Pfizer Inc. (NYSE: PFE) and Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that the United States Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis. The FDA Prescription Drug User Fee Act (PDUFA) date is October 3, 2013.

BZA/CE pairs the selective estrogen receptor modulator (SERM) bazedoxifene with conjugated estrogens. BZA/CE has been studied in a Phase III clinical development program (Selective estrogens, Menopause And Response to Therapy [SMART] trials), which included approximately 7,500 postmenopausal women and assessed the safety and efficacy of BZA/CE for the treatment of moderate-to-severe VMS and VVA associated with menopause, as well as the prevention of postmenopausal osteoporosis. The most common adverse drug reactions observed in the SMART trials were abdominal pain, vaginal yeast infection and muscle spasms.

Posted-In: News FDA

 

Related Articles (LGND + PFE)

View Comments and Join the Discussion!