FDA declines to approve Botox rival

US health regulators have declined to approve Evolus Inc’s rival product to Allergan’s Botox, citing deficiencies related to the chemistry, manufacturing and controls processes of its potential treatment for frown lines and sending its shares down as much as 35%. 

The deficiencies cited by the Food and Drug Administration (FDA) were “manageable”, according to chief executive officer David Moatazedi, who joined the company earlier this month after serving as US head of Allergan’s medical aesthetics business. 

The company said it was committed to getting its DWP-450, which is being developed to treat glabellar lines or frown lines in adult patients, to the market by spring 2019. Evolus expects to respond to the FDA with a complete submission within 90 days. 

Allergan’s Botox is the market leader for treatment of wrinkles and frown lines, but the threat of looming competition for the blockbuster treatment had put some pressure on the drugmaker. However, news of the delay for Evolus’s treatment sent Allergan’s shares up