The United States Food and Drug Administration (FDA) has approved Bayer\u2019s drug to ease hot flashes in menopausal women, the German company said on Oct 24, a welcome development following the regulator\u2019s three-month review extension.<\/p>\n
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.<\/p>\n
Bayer said Lynkuet, a once-daily capsule to be taken at bedtime, is expected to be available in the US from November.<\/p>\n
The drug\u2019s wholesale cost is US$625 (S$812) for a month\u2019s supply, though patient costs vary based on insurance, the company said. It has partnered online pharmacy BlinkRx, through which eligible patients may pay as little as US$25 a month via the Lynkuet Access, Savings and Support programme.<\/p>\n
The FDA\u2019s 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.<\/p>\n
Bayer has been gearing up to launch the drug this year, projecting annual peak sales of at least US$1 billion, a strategic move to bolster its pharmaceutical business amid mounting debt pressures.<\/p>\n
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.<\/p>\n
The drug is already approved in Australia, Canada, Britain and Switzerland. An application is pending in the European Union.<\/p>\n
Japanese drugmaker Astellas\u2019 non-hormonal, oral treatment Veozah is the other approved treatment in the US for hot flashes associated with menopause. REUTERS <\/p>\n
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