Pfizer, Ligand announce FDA acceptance of bazedoxifene/conjugated estrogens NDA

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.

"Pfizer is dedicated to advancing treatments that may help improve health and well-being at each stage of life," said Gail Cawkwell, M.D., Ph.D., vice president, Pfizer's Medical Affairs. "BZA/CE was developed for non-hysterectomized women with moderate-to-severe menopausal symptoms. This milestone moves us one step closer towards potentially providing the first new treatment option in the U.S. in years for the treatment of these women's menopausal symptoms."

BZA/CE was developed by Wyeth Pharmaceuticals and was part of a broader research collaboration with Ligand on SERMs. Pfizer acquired the rights to BZA/CE when it acquired Wyeth.

"Pfizer continues to make good progress with this program, with this NDA submission shortly following the European Marketing Authorization Application submission earlier this year," said John Higgins, president and chief executive officer, Ligand. "This is an important therapeutic need, and we commend Pfizer for its continued strong commitment to the program."

Source:

Pfizer Inc.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Ultra-processed foods dominate children's diets from toddlerhood to middle childhood