FDA delays approval decision for Bayer menopause therapy

The Food and Drug Administration has delayed its review of a Bayer therapy for hot flashes related to menopause, telling the drugmaker it needs additional to review the company’s application.

In a Friday statement, Bayer said the FDA did not raise any concerns around “general approvability” of the drug, called elinzanetant. Still, the agency extended its decision deadline by three months.

“With the consistent positive results from our clinical Phase III program assessing the efficacy and safety of elinzanetant, we remain confident about elinzanetant’s potential as a new treatment option for moderate to severe vasomotor symptoms associated with menopause,” Christian Rommel, Bayer’s global head of research and development, said in a statement.

Bayer submitted elinzanetant last August based on three large late-stage studies known as OASIS 1, 2 and 3. Data showed treatment reduced the severity and frequency of vasomotor symptoms, also known as hot flashes, in women given the drug versus those who received placebo.

If approved, elinzanetant would join Astellas Pharma’s Veozah on the market as a non-hormonal option for menopausal women.

While hot flashes can also be treated with hormonal therapy, the FDA warns of an increased risk of cardiovascular events and cancers in some women. (A group of experts convened by FDA head Martin Makary this week called for the agency to modify hormone therapy’s warning labeling, arguing it unnecessarily limits use.)

Elinzanetant works similarly to Veozah, targeting a receptor known as neurokinin 3, as well as another dubbed neurokinin 1. Both receptors are involved in regulating body temperature.

Bayer’s drug could have a competitive edge over Veozah, however. Veozah has struggled to take off commercially, and the FDA recently added a black box warning to its labeling for the risk of liver injury. Bayer has not reported similar side effects from testing of its drug.

The U.K. and Canada recently approved elinzanetant, which Bayer will sell under the brand name Lynkuet there.

“As we continue to work with the FDA during the ongoing review, we are fully committed to making elinzanetant available to women in the U.S. as soon as we receive FDA approval,” Rommel said in a statement.

The FDA has missed, or extended, its approval deadlines for several other drugs in recent months.

In a recent analysis of FDA approval deadlines, analyst Brian Abrahams and his team at RBC Capital Markets found “some potentially concerning signals of greater missed target dates.” However, they noted that’s it difficult to tell whether this stems from a “more methodical approach” or resource limitations at the agency, or from drug company missteps.

Their analysis, Abrahams wrote, “does suggest delay risk” for drugmakers with decision deadlines in the second half of this year.

This post has been syndicated from a third-party source. View the original article here.