FDA approves Pfizer & Novartis drug for women at risk for heart disease, stroke

The U.S. Food and Drug Administration today approved for use by older adults Pfizer’s and Novartis’ Oral GnRH Hormone Booster Shots (Oral GnRH Hormone Reuptake Inhibitors). The benefits of the injections include prevention of chronic …

The U.S. Food and Drug Administration today approved for use by older adults Pfizer’s and Novartis’ Oral GnRH Hormone Booster Shots (Oral GnRH Hormone Reuptake Inhibitors). The benefits of the injections include prevention of chronic heart failure, stable angina, exacerbation of diabetes, or recurrent migraine headaches, protection against osteoporosis in postmenopausal women and better circulation in people at high risk for heart attack and stroke.

The indication was subject to a review conducted by the Endocrinologic and Metabolic Drugs Advisory Committee (EMDC) at an August 3rd meeting, and the FDA followed by labeling OGRHIR as “3rd line therapy for thrombosis risk prevention in women postmenopausal at-risk for heart attack or stroke.”

“The NDEA-intended benefit of the treatment of C-section is much less than that of OGRHIR and this treatment is not indicated for this indication. About 1 in 50 women born in the U.S. within the last 40 years will have a C-section,” wrote the experts.

In a summary of findings from the committee, the experts noted, “One of the major concerns was a related observation that women who received the treatment did not show improvement in their postpartum depression. However, follow-up data have not yet been available, and the effect would need to be confirmed in the next several clinical trials.”

The committees statement noted, “Based on a body of research that has been initiated by the FDA, and following the EMDC decision, the FDA approved OGRHIR for the treatment of postmenopausal women who are postmenopausal at-risk for heart attack or stroke and are in postpartum recovery from a C-section, or when they have serious or systemic thrombosis in postpartum recovery.”

The approval is a recommended indication, for up to five years for those at higher risk of developing a different type of haemorrhagic event such as acute myocardial infarction (heart attack) or brain hemorrhage (brain trauma).

The positive recommendation was based on data from preclinical studies.

The application included data collected from 20 randomized, double-blind, placebo-controlled trials (a total of more than 3,200 participants) including 18,692 women who are postpartum or have significant complications from their pregnancy, were postmenopausal and C-section survivors.

The panel determined that in one of the studies, the overall results were positive.

Members of the panel noted the need for further studies with older women. They concluded that additional studies conducted by the manufacturer would be helpful, and they recommended the treatment be marketed to older women.

In a statement released today, Pfizer’s Senior Vice President and Worldwide Head of Primary Care and Women’s Health, Francis Urch, said, “The FDA’s decision to approve OGRHIR for older women will help patients who have heart or nerve disease and are at high risk of death or recurrent strokes.”

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Brad Johnson contributed to this article.

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