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US FDA rejects Evolus' wrinkles treatment delaying rival to Allergan's Botox

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US FDA rejects Evolus' wrinkles treatment delaying rival to Allergan's Botox

Evolus Inc. said the U.S. Food and Drug Administration rejected the application for its wrinkles treatment prabotulinumtoxinA.

The biologics license application requested an indication for prabotulinumtoxinA, or DWP-450, to treat glabellar lines, also known as frown lines, in adult patients.

PrabotulinumtoxinA is expected to compete with Allergan PLC's wrinkles therapy Botox, after the drug was shown to have worked as well as Botox in improving the appearance of frown lines.

The regulator issued a complete response letter citing deficiencies related to chemistry, manufacturing and controls processes. There were no deficiencies related to clinical or nonclinical matters.

Evolus will work closely with the FDA and expects to launch DWP-450 in the market by spring 2019, said David Moatazedi, president and CEO of Evolus.

Irvine, Calif.-based Evolus said it expects to respond with a complete submission to the FDA within 90 days.

The FDA, however, cleared its manufacturing partner Daewoong Pharmaceutical Co. Ltd.'s South Korean plant as part of a preapproval inspection.