(Reuters) -The U.S. Food and Drug Administration has approved Bayer’s drug to ease hot flashes in menopausal women, the German company said on Friday, a welcome development following the regulator’s three-month review extension.
The drug, branded as Lynkuet, is a non-hormonal treatment designed to relieve moderate-to-severe vasomotor symptoms, also known as hot flashes, associated with menopause.
Bayer said Lynkuet, a once-daily capsule to be taken at bedtime, is expected to be available in the U.S. beginning November.
The drug’s wholesale cost is $625 for a month’s supply, though patient costs vary based on insurance, the company said. It has partnered with online pharmacy BlinkRx, through which eligible patients may pay as little as $25 a month via the Lynkuet Access, Savings and Support program.
The FDA’s approval for Lynkuet was based on three late-stage studies that showed the drug reduced the frequency and severity of hot flashes and eased sleep disturbances in menopausal women.
Bayer has been gearing up to launch the drug this year, projecting annual peak sales of at least $1 billion, a strategic move to bolster its pharmaceuticals business amid mounting debt pressures.
Its label, however, warns about possible drowsiness, increases in liver enzymes, risk of pregnancy loss, and seizures in people with a seizure history. Patients are advised to avoid grapefruit during treatment, Bayer said.
The drug is already approved in Australia, Canada, the UK and Switzerland. An application is pending in the European Union.
Japanese drugmaker Astellas’ non-hormonal, oral treatment Veozah is the other approved treatment in the U.S. for hot flashes associated with menopause.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Shilpi Majumdar)
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