Bayer’s Lynkuet wins FDA approval

The US Food and Drug Administration (FDA) has approved German pharma major Bayer’s (BAYN: DE) Lynkuet (elinzanetant) 60mg capsules, the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause.

Bayer noted that inhibition of substance P and neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in the thermoregulation associated with hot flashes. Lynkuet soft gel capsules are taken once daily at bedtime, with or without food. The FDA approval is supported by data from three Phase III clinical trials (OASIS 1, OASIS 2 and OASIS 3) that evaluated the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause.